MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 6X50MM S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186760450S
Medical Device Problem Codes	Difficult to Advance (2920); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 during a surgery on (b)(6) 2026, after inserting the screw in question, an alignment device was placed for cement injection.The surgeon commented that the fixation force was weaker than with other screws.The open cannula was able to be inserted same as the other screws, but instead of the polylock that should have been applied when the alignment device was placed, the head of the screw in question moved.The surgeon commented that he had also felt discomfort when inserting the screw.After removing the screw in question and replacing it with a screw of a larger diameter, the discomfort during screw insertion and the movement of the head after the alignment device was placed disappeared.Cement was then injected as usual, and the surgery was completed successfully with no surgical delay.After the surgery, the surgeon commented that the screw sometimes did not advance and would spin freely during insertion.No further information is available.
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.H11 additional narrative: h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a nonconformance.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed as mating devices were not returned.The overall complaint was not confirmed as the observed condition of the viper prime cfxfn xtb 6x50mm s would have not 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 history lot: a dhr evaluation was performed for the finished device.Product code: 186760450s.Lot number: tbapvr.The product was released on: 26.03.2025.Manufacturing site: jabil le locle.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.H11 additional narrative: added: d9 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 CFXFN XTB 6X50MM S
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24248229
• Report Number: 1526439-2026-00094
• Device Sequence Number: 21247086
• Product Code: NKB
• UDI-Device Identifier: 10705034530109
• UDI-Public: (01)10705034530109(17)300131(10)TBAPVR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 186760450S
• Device Lot Number: TBAPVR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 03/19/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/23/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown