MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186770150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
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 a transforaminal lumbar interbody fusion (tlif) (l4/5) was performed on (b)(6) 2018.After the initial surgery, adjacent segment disease occurred, and a revision surgery was performed on (b)(6) 2023.This report involves one viper system x-tab cortical fix polyaxial screw 5.5 7.0mm x 50mm.This report is related to (b)(4), which reports difficulties encountered in the revision surgery.This report is related to (b)(4), which reports the rods involved in the event.This is report 8 of 9 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D2b: additional device product codes: mnh, kwp, mni, osh, kwq 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.H10 additional narrative: a review of the receiving inspection (ri) for cortical fix x-tab 7x50mm ti was conducted identifying that lot number tbmnk released in one batch.Batch1: lot units were released jul 15, 2016 with no discrepancies.Supplier: (b)(4).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.

• Brand Name: VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17862141
• Report Number: 1526439-2023-01888
• Device Sequence Number: 20379181
• Product Code: NKB
• UDI-Device Identifier: 10705034465807
• UDI-Public: (01)10705034465807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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

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: 186770150
• Device Lot Number: TBMNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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: 5.5 TI CORT FIX 7X55MM; CONCORDE BUL PAR 9X11X27; CORTICAL FIX X-TAB 7X50MM TI; CORTICAL FIX X-TAB 7X50MM TI; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; UNKNOWN SCREWS; VIPER2 STRAIGHT ROD-300MM,COCR; VIPER2 STRAIGHT ROD-300MM,COCR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown