Kiri

FIELD SAFETY CORRECTIVE ACTION - RECALL

REC 2024-01

IMMEDIATE ACTION REQUIRED

Recipient: Customers, Distributors and Sales Department Affected Product: HPS 2.0 Rod coupler, S=25N/mm, 27mm Manufacturer Paradigm Spine GmbH Date of Recall 17.07.2024 Type of Recall Field Safety Corrective Action (FSCA) Item, lot and UDI number:

Item Number LOT Number UDI Number HBI92527 1321000344 (01)04260148891649(17)290731(10)1321000344 HBI92527 1321000352 (01)04260148891649(17)290731(10)1321000352 HBI92527 1322000026 (01)04260148891649(17)300430(10)1322000026 HBI92527 1322000072 (01)04260148891649(17)300531(10)1322000072 HBI92527 1322000073 (01)04260148891649(17)300531(10)1322000073 HBI92527 1322000074 (01)04260148891649(17)300531(10)1322000074 HBI92527 1322000075 (01)04260148891649(17)300630(10)1322000075

Reason for FSCA It has been determined that the internal thread of the rod coupler within the specified batches was manufactured out of the specified tolerances. This may result in the corresponding rod not being able to be fully screwed in.

Clinical Effect If the case described above occurs, the surgery may be delayed until the defective rod coupler has been replaced. If no replacement is available, it is necessary to deviate from the planned procedure and perform a fusion.

Action Required We would like you to identify all affected products in your warehouse as well as in your field inventory in the hospitals and return them immediately for inspection and quarantine. These items must not be sold or used. Please fill in the attached form to confirm that you have inspected your inventory and that the affected parts will be returned or have been already used.

Transmission of this Recall

This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (If appropriate).

Further Information For further questions related to this Field Safety Corrective Action (FSCA) do not hesitate to contact our customer sales department at: Paradigm Spine GmbH Eisenbahnstraße 84 78573 Wurmlingen / Germany [email protected] Tel.: +49(0)7461 963599-0 We deeply regret the inconvenience and will take all possible corrective and preventive action to avoid this in the future. We appreciate your quick response, your cooperation and your understanding.

CONFIRMATION OF RECEIPT

Please sign and return to Paradigm Spine GmbH

I hereby confirm that I have received this Notice.

Date:

Signature:

Confirmation of Inventory

Please return this form to Paradigm Spine by fax or email.

Fax: +49(0)7461 963599-20 / Email: [email protected]

According to our traceability records you have received items of the recalled lots. Please check your inventory and your accounts in your territory.

Item number Lot number Qty. Delivery date

In inventory or accounts

yes/no

Will be returned yes/no

Already implanted

yes/no

Please complete the table above and sign below to confirm that you checked your inventory, your accounts in your territory and that you informed your customers, if applicable.

Company: _______________________

Print Name: _______________________

Signature: _______________________

Position/title: _______________________

Date: _______________________

Please send the affected items separately (not mixed with other products) to the following address using recall number REC 2024-01.

Paradigm Spine GmbH Eisenbahnstraße 84 78573 Wurmlingen Germany Attn: QA Department / Recall 2024-01

You will receive replacement implants immediately.

National Competent Authority Report (NCAR) according to Regulation (EU) 2017/745 or Directive 98/79/EC DE-BfArM-2024-07-30-4754 BfArM case number: 23795/24 Dear Sir or Madam Please find enclosed a National Competent Authority Report, in accordance with the relevant Regulation or Directive. Enquiries should be submitted to the Federal Institute for Drugs and Medical Devices (BfArM), Medical Devices Division, e-mail:

[email protected].

Please inform us about changes in your e-mail address. Yours faithfully

Medical Devices Division

On behalf of the Federal Institute for Drugs and Medical Devices

This letter was created electronically and is valid without signature.

Attachment: NCAR DE-BfArM-2024-07-30-4754

DIVISION Medical Devices

NAME Jerome Brückner

TELEPHONE +49 (0)228 99 307- 5365

E-MAIL [email protected]

ADDRESS Kurt-Georg-Kiesinger-Allee 3

53175 Bonn

TELEPHONE +49 (0)228 99 307-0

TELEFAX +49 (0)228 99 307-5207

E-MAIL [email protected]

INTERNET www.bfarm.de

Bonn, 30.07.2024 OUR REF 91.31-23795/24

BfArM, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn

To whom it may concern

FIELD SAFETY CORRECTIVE ACTION - RECALL

REC 2024-01

IMMEDIATE ACTION REQUIRED

Recipient: Customers, Distributors and Sales Department Affected Product: HPS 2.0 Rod coupler, S=25N/mm, 27mm Manufacturer Paradigm Spine GmbH Date of Recall 17.07.2024 Type of Recall Field Safety Corrective Action (FSCA) Item, lot and UDI number:

Item Number LOT Number UDI Number HBI92527 1321000344 (01)04260148891649(17)290731(10)1321000344 HBI92527 1321000352 (01)04260148891649(17)290731(10)1321000352 HBI92527 1322000026 (01)04260148891649(17)300430(10)1322000026 HBI92527 1322000072 (01)04260148891649(17)300531(10)1322000072 HBI92527 1322000073 (01)04260148891649(17)300531(10)1322000073 HBI92527 1322000074 (01)04260148891649(17)300531(10)1322000074 HBI92527 1322000075 (01)04260148891649(17)300630(10)1322000075

Reason for FSCA It has been determined that the internal thread of the rod coupler within the specified batches was manufactured out of the specified tolerances. This may result in the corresponding rod not being able to be fully screwed in.

Clinical Effect If the case described above occurs, the surgery may be delayed until the defective rod coupler has been replaced. If no replacement is available, it is necessary to deviate from the planned procedure and perform a fusion.

Action Required We would like you to identify all affected products in your warehouse as well as in your field inventory in the hospitals and return them immediately for inspection and quarantine. These items must not be sold or used. Please fill in the attached form to confirm that you have inspected your inventory and that the affected parts will be returned or have been already used.

Transmission of this Recall

This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (If appropriate).

Further Information For further questions related to this Field Safety Corrective Action (FSCA) do not hesitate to contact our customer sales department at: Paradigm Spine GmbH Eisenbahnstraße 84 78573 Wurmlingen / Germany [email protected] Tel.: +49(0)7461 963599-0 We deeply regret the inconvenience and will take all possible corrective and preventive action to avoid this in the future. We appreciate your quick response, your cooperation and your understanding.

CONFIRMATION OF RECEIPT

Please sign and return to Paradigm Spine GmbH

I hereby confirm that I have received this Notice.

Date:

Signature:

Confirmation of Inventory

Please return this form to Paradigm Spine by fax or email.

Fax: +49(0)7461 963599-20 / Email: [email protected]

According to our traceability records you have received items of the recalled lots. Please check your inventory and your accounts in your territory.

Item number Lot number Qty. Delivery date

In inventory or accounts

yes/no

Will be returned yes/no

Already implanted

yes/no

Please complete the table above and sign below to confirm that you checked your inventory, your accounts in your territory and that you informed your customers, if applicable.

Company: _______________________

Print Name: _______________________

Signature: _______________________

Position/title: _______________________

Date: _______________________

Please send the affected items separately (not mixed with other products) to the following address using recall number REC 2024-01.

Paradigm Spine GmbH Eisenbahnstraße 84 78573 Wurmlingen Germany Attn: QA Department / Recall 2024-01

You will receive replacement implants immediately.

National Competent Authority Report (NCAR) according to Regulation (EU) 2017/745 or Directive 98/79/EC DE-BfArM-2024-07-30-4754 BfArM case number: 23795/24 Dear Sir or Madam Please find enclosed a National Competent Authority Report, in accordance with the relevant Regulation or Directive. Enquiries should be submitted to the Federal Institute for Drugs and Medical Devices (BfArM), Medical Devices Division, e-mail:

[email protected].

Please inform us about changes in your e-mail address. Yours faithfully

Medical Devices Division

On behalf of the Federal Institute for Drugs and Medical Devices

This letter was created electronically and is valid without signature.

Attachment: NCAR DE-BfArM-2024-07-30-4754

DIVISION Medical Devices

NAME Jerome Brückner

TELEPHONE +49 (0)228 99 307- 5365

E-MAIL [email protected]

ADDRESS Kurt-Georg-Kiesinger-Allee 3

53175 Bonn

TELEPHONE +49 (0)228 99 307-0

TELEFAX +49 (0)228 99 307-5207

E-MAIL [email protected]

INTERNET www.bfarm.de

Bonn, 30.07.2024 OUR REF 91.31-23795/24

BfArM, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn

To whom it may concern

NATIONAL COMPETENT AUTHORITY REPORT This form should be used for the exchange of medical device information between NCAR participants only.

Completed forms should not be released to the public.

1. Is this report confidential? Yes [ ] No [ X ]

Reference and Reporter Data

2. NCA report ref. no.:

DE-BfArM-2024-07-30-4754

3. Local NCA reference no.:

23795/24

4. Related NCA report nos.: (if any)

5. Manufacturer Ref/Recall no.:

REC 2024-01

6. Sent by: (Name and Organization)

BfArM, Division Medical Devices

7. Contact person: (if different from 6)

Rainer Harhammer

8. Tel:

+49 228 207 - 5390

9. Fax:

+49 228 207 - 5300

10. E-mail:

[email protected] Device Data 11. Generic name/ kind of device: Spinal dynamic-stabilization system 20. CAB/Notified Body no.:

12. Nomenclature id: GMDN 13. No.: 58446 0123

14. Trade Name and Model / Catalogue: HPS 2.0 Rod coupler, S=25N/mm, 27mm ; N/A /

HBI92527 21a. Device approval status:

15. Software version: N/A 16. Serial no.:

N/A

17. Lot/batch no.:

Please see REC 2024-01 Product List 21b. Risk Class: MDD Class

IIb 18. Manufacturer:

Paradigm Spine GmbH

Country:

DE

Full Address:

Eisenbahnstrasse 84

78573

Wurmlingen

Contact:

Camilla-Noémi Sommer

Tel:

07461963599-0

Fax:

07461963599-20

E-mail:

[email protected]

19. Authorized rep:

Country:

Full Address:

Contact:

Tel:

Fax:

E-mail:

22. Action taken:

[ ] None

[ ] Safeguard Action

[X] Field Safety Corrective

Action

[ ] Other (specify)

Event Data

23a. Background information and reason for this report:

The manufacturer has informed BfArM about a corrective action concerning the above mentioned device.

23b. Is the investigation of the report complete? Yes [ X ] No [ ]

24a. Conclusions:

The manufacturer issued the enclosed FSN.

24b. Have the manufacturer’s actions been made public? Yes [ X ] No [ ]

24c. The originator of this NCAR will take the lead and co-ordinate the investigation - Yes [ X ] No [ ] 25a. Recommendation to receivers of this report:

For your information and be aware of the problem.

25b. Device known to be in the market in (include copy of manufacturer’s letter):

AT, DE, GB, IT

25c. Device also marketed as (trade name):

Report Distribution

26a. This report is being distributed to:

[ ] The NCAR Secretariat for further distribution to FULL NCAR PARTICIPANTS.

[ ] The NCAR Secretariat for further distribution to ALL NCAR PARTICIPANTS.

[X] EEA states, EC, and EFTA

[ ] The following targeted NCAs:

[X] The manufacturer / authorized rep.: Paradigm Spine GmbH /

NATIONAL COMPETENT AUTHORITY REPORT This form should be used for the exchange of medical device information between NCAR participants only.

Completed forms should not be released to the public.

1. Is this report confidential? Yes [ ] No [ X ]

Reference and Reporter Data

2. NCA report ref. no.:

DE-BfArM-2024-07-30-4754

3. Local NCA reference no.:

23795/24

4. Related NCA report nos.: (if any)

5. Manufacturer Ref/Recall no.:

REC 2024-01

6. Sent by: (Name and Organization)

BfArM, Division Medical Devices

7. Contact person: (if different from 6)

Rainer Harhammer

8. Tel:

+49 228 207 - 5390

9. Fax:

+49 228 207 - 5300

10. E-mail:

[email protected] Device Data 11. Generic name/ kind of device: Spinal dynamic-stabilization system 20. CAB/Notified Body no.:

12. Nomenclature id: GMDN 13. No.: 58446 0123

14. Trade Name and Model / Catalogue: HPS 2.0 Rod coupler, S=25N/mm, 27mm ; N/A /

HBI92527 21a. Device approval status:

15. Software version: N/A 16. Serial no.:

N/A

17. Lot/batch no.:

Please see REC 2024-01 Product List 21b. Risk Class: MDD Class

IIb 18. Manufacturer:

Paradigm Spine GmbH

Country:

DE

Full Address:

Eisenbahnstrasse 84

78573

Wurmlingen

Contact:

Camilla-Noémi Sommer

Tel:

07461963599-0

Fax:

07461963599-20

E-mail:

[email protected]

19. Authorized rep:

Country:

Full Address:

Contact:

Tel:

Fax:

E-mail:

22. Action taken:

[ ] None

[ ] Safeguard Action

[X] Field Safety Corrective

Action

[ ] Other (specify)

Event Data

23a. Background information and reason for this report:

The manufacturer has informed BfArM about a corrective action concerning the above mentioned device.

23b. Is the investigation of the report complete? Yes [ X ] No [ ]

24a. Conclusions:

The manufacturer issued the enclosed FSN.

24b. Have the manufacturer’s actions been made public? Yes [ X ] No [ ]

24c. The originator of this NCAR will take the lead and co-ordinate the investigation - Yes [ X ] No [ ] 25a. Recommendation to receivers of this report:

For your information and be aware of the problem.

25b. Device known to be in the market in (include copy of manufacturer’s letter):

AT, DE, GB, IT

25c. Device also marketed as (trade name):

Report Distribution

26a. This report is being distributed to:

[ ] The NCAR Secretariat for further distribution to FULL NCAR PARTICIPANTS.

[ ] The NCAR Secretariat for further distribution to ALL NCAR PARTICIPANTS.

[X] EEA states, EC, and EFTA

[ ] The following targeted NCAs:

[X] The manufacturer / authorized rep.: Paradigm Spine GmbH /