MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186760445
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
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.H11 additional narrative: d2b: additional device product codes: kwp, kwq.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device was broken from the threaded shaft.No postoperative x-rays were provided to confirm the embedded device, therefore this allegation can't be confirmed.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the viper prime cfxfen xtab 6x45mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.Device history review (dhr): a review of the receiving inspection (ri) for viper prime cfxfen xtab 6x45mm was conducted identifying that lot number tbzny was released in one batch.Batch1: lot qty of (b)(4)were released on jun 24, 2019 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.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
It was reported that on (b)(6) 2024, it was identified before the case that three screws had broken postoperatively in the patient.Two viper prime cfxfen xtab 5x45mm broke at the t12 level and one viper prime cfxfen xtab 6x45mm broke at the l2 level on the left.All screws were removed.The three broken screws were mostly removed, but fragments were left in the vertebrae.This report involves one viper prime cfx fen x-tab polyaxial screw 5.5 6 x 45mm.This is report 3 of 3 for (b)(4).

• Brand Name: VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 20133938
• Report Number: 1526439-2024-02245
• Device Sequence Number: 7350157
• Product Code: NKB
• UDI-Device Identifier: 10705034509402
• UDI-Public: (01)10705034509402(10)TBZNY
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 186760445
• Device Lot Number: TBZNY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2019
• 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: VIPER PRIME CFXFEN XTAB 6X45MM; VIPER PRIME CFXFEN XTAB 6X45MM; VIPER PRIME CFXFEN XTAB 6X45MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown