MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER 2 SYSTEM ROD, PRE-LORDOSED 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	186788045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent a tlif (l4/5).After the surgery, adjacent segment disease occurred.A revision surgery to extend fixation was scheduled for (b)(6) 2023.This report involves one viper 2 system rod, pre-lordosed 45mm.This report is related to (b)(4), which captures additional impacted products.This is report 10 of 10 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b3: only the event year is known.D2b: additional device product codes: kwp, mnh, kwq, osh, mni.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H4: manufacture date added.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history review (dhr): a review of the receiving inspection (ri) for viper2 lordotic rod-45mm was conducted identifying that lot number csaarj was released in one batch.Supplier: (b)(4).¿ batch1: lot qty of (b)(4) units were released on 09 june 2022 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: event description added device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The revision surgery was performed on (b)(6) 2023, as scheduled, and it was completed with no problems.The following procedures were done in the revision surgery.L3/4: xlif was performed.L4/5: set screws and rods inserted in the initial surgery were removed.L2 and l3: diameter 6.0 - length 50 mm viper prime screws were inserted.S: diameter 6.0 - length 45 mm viper prime screw was inserted.L2/s: diameter 5.5 mm viper rod was inserted.Set screws were inserted and the final tightening was done.

• Brand Name: VIPER 2 SYSTEM ROD, PRE-LORDOSED 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17923225
• Report Number: 1526439-2023-02020
• Device Sequence Number: 6782790
• Product Code: NKB
• UDI-Device Identifier: 10705034131740
• UDI-Public: (01)10705034131740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 186788045
• Device Lot Number: CSAARJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 01/18/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/03/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCORDE PROTI, P, 9X7X23 MM; CONCORDE PROTI, P, 9X7X23 MM; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; VIPER PRIME CFX XTAB 6X50MM TI; VIPER PRIME CFX XTAB 6X50MM TI; VIPER PRIME CFX XTAB 6X50MM TI; VIPER PRIME CFX XTAB 6X50MM TI; VIPER2 LORDOTIC ROD-45MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown