MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VELYS NAVIGATION STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451611000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open lumbar procedure, the doctor was using verse.Final placement of screws was higher than what was on the nav screen.Surgeon believes there was a shift that caused the placement to be moved.There were no reports of injuries, medical intervention or prolonged hospitalization.No patient treatments were delayed or cancelled.
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 report, a follow-up report 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: investigation summary: log file analysis has been performed by tpm team, using spine log viewer (version 1.1), based on event date and event description.While date of event correspond to the provided logs, the event description does not match with any of the logs provided.As such, both provided procedures were analyzed.Both procedures were about: - open procedures - verse screws planned - patient array clamped on t11 - same practitioner logged in however, the log review did not show any evidence matching the reported event, nor potential phenomenon that could have caused such event.In particular, - no evidence of patient array motion (matching the reported "shift") - no evidence of degraded accuracy during anatomy checks (matching the reported "shift") performed before each screw placement.Furthermore, no post-operative fluoroscopies or 3d image have been provided to support complementary assessment of the allegation ("final placement of screws was higher than what was on the nav screen").Even though additional information have been requested for additional matching cues, no answer have been provided, so that the allegation remains unconfirmed.There were no defects found with the device.Beyond surgical delay, the user indicated that there was no reports of injuries, medical intervention or prolonged hospitalization.This issue will be continued to be monitored through complaint trending as part of post market surveillance.Root cause: no defects found with the device.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review: no manufacturing record evaluation required as no manufacturer or service related issue found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VELYS NAVIGATION STATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: elba bello ; chemin blanc 38; le locle ; SZ ; 9083863534
• MDR Report Key: 24619887
• Report Number: 1526439-2026-00264
• Device Sequence Number: 21377718
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K233228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 451611000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown