MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX XTAB 7X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186770345S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code: kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a tlif (transforaminal lumbar interbody fusion) in the lumbar spine treating degenerative disease.During the procedure, the surgeon was not able to apply torque on screws (unk) and setscrews (unk) during final fixation.The procedure was completed with replacements less than 30-minute surgical delay.The patient outcome was unknown.Concomitant device reported: unknown torque device (part# unknown, lot# unknown, quantity unknown).This report is for (1) viper prime cfx xtab 7x45mm ti.This report is 5 of 5 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.H10 additional narrative: d9: updated h3, h6: investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the viper prime cfx xtab 7x45mm ti implant.The dimensional inspection was not performed as no damages were observed on the device.The alleged functional issue was attributed to the mating set screw, as it's internal drive feature was deformed.As part of depuy spine quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the viper prime screw implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.The complaint condition was not confirmed as no damage was observed with the viper prime cfx xtab 7x45mm ti during the investigation.While no definitive root cause could be determined, the alleged functional issue was isolated to the mating set screw due to its deformed drive feature.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? the related drawing are reflecting the current and manufactured revisions were reviewed.Device history lot the dhr of product code: 186770345s.Lot : tbadbt.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 18.03.2020 qty: (b)(4).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 PRIME CFX XTAB 7X45MM TI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11077036
• MDR Text Key: 223799101
• Report Number: 1526439-2020-02484
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034530185
• UDI-Public: (01)10705034530185
• Combination Product (y/n): N
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186770345S
• Device Catalogue Number: 186770345S
• Device Lot Number: TBADBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 01/29/2021
• Patient Sequence Number: 1
• Treatment: VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI