MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 40MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 186731740

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

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.Additional device product codes: nkb, mni, kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Reporter is a j&j employee.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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that the patient underwent a spinal fusion (l3/4) on (b)(6) 2014.After surgery, adjacent intervertebral disorder occurred at l2/3 and l4/5.On (b)(6) 2023, a reoperation was performed.In the reoperation, set screws and rods of l3/4 were removed, and screws were added to l2 and l5.Tlif treating l2/3 and tlif treating l4/5 were done.The patient outcome was reported to be stable.There is no problem in the fusion site treated in the initial surgery in 2024.This report involves one viper system cortical fix polyaxial screw 5.5 7 x 40mm.This is report 4 of 7 for (b)(4).

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.Part # 186731740.Lot # tberf.Supplier: tomz corp.¿ batch1: lot units were released on 26 april 2013 with no discrepancies.No non conformance reports were generated during production.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 CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 40MM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• 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: 16644042
• MDR Text Key: 312312130
• Report Number: 1526439-2023-00630
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034352008
• UDI-Public: (01)10705034352008
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 186731740
• Device Catalogue Number: 186731740
• Device Lot Number: TBERF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X40MM.; 5.5 TI CORT FIX 7X45MM.; 5.5 TI CORT FIX 7X45MM.; MMSI ROD, 5.5 X 45MM, TI.; MMSI ROD, 5.5 X 45MM, TI.; SFX,5.5,TI, MED, SIZE A5.
• Patient Outcome(s): Required Intervention