MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX XTAB 7X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770340S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code kwp,kwq.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: a review of the receiving inspection (ri) for viper prime cfx xtab 7x40mm ti-sterile was conducted identifying that lot number tbyfh was released in a single batch.Batch1: lot qty of (b)(4) units were released on (b)(6) 2019 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 history review: 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for plif ( posterior lumbar interbody fusion) at l4-5 treating spondylolisthesis.During the surgery, it was found that two screws had come off the pedicle.The lesion was deployed again, and the 1st screw was removed without difficulty but difficult to pick up the 2nd screw.Finally, the 2nd screw was removed, and the surgery completed successfully with 30 minutes delay.The patient outcome was unknown.This complaint involves two (2) devices.This report is for (1) viper prime cfx xtab 7x40mm ti.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: d4: udi 01/06/2021: updated manufactured date to 6/12/2019, of (b)(4).D11: concomitant product added to complaint.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 7X40MM TI
• Common Device Name: 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: 10952296
• Report Number: 1526439-2020-02362
• Device Sequence Number: 19538136
• Product Code: NKB
• UDI-Device Identifier: 10705034530178
• UDI-Public: 10705034530178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186770340S
• Device Catalogue Number: 186770340S
• Device Lot Number: TBABJC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 02/01/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/20/2021; 02/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER PRIME CFX XTAB 7X40MM TI; VIPER PRIME CFX XTAB 7X40MM TI
• Outcome Attributed to Adverse Event: Required Intervention