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	10/09/2025
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.
Event or Problem Description
It was reported that the l2-l4 mis pedicle screw case.The doctor started l2-l3 on the right side.He stated that he felt that the knife jig was not helping him get the proper trajectory so he transitioned from using the robot to freehand placement for the incision for l4 right.He continued freehand placement on l2 left to l4 left.The final x-ray found and an o-arm spin confirmed that the left l2 screw was both high and lateral compared to plan.They completed another spin, replanned the left l2 with the navigation and robot and the revised placement was acceptable to the surgeon.It was approximately a 60 minutes delay.All information has been disclosed.No further information was provided.
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: d10.Corrected: h4.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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: according to the information received, the issue with the following product: 451611000 sn: (b)(6) was experienced: l2-l4 mis pedicle screw case.The doctor started l2-l3 on the right side.He stated that he felt that the knife jig was not helping him get the proper trajectory so he transitioned from using the robot to freehand placement for the incision for l4 right.He continued freehand placement on l2 left to l4 left.The final x-ray found and an o-arm spin confirmed that the left l2 screw was both high and lateral compared to plan.They completed another spin, replanned the left l2 with the navigation and robot and the revised placement was acceptable to the surgeon.The reported issues could not be confirmed for the navigation station.As per log file review, user related issues were found related to the robotic-assisted station and the use of its robotic arm.More details can be found under (b)(4).The photos and video provided by the reporter are not indicating any defects with the navigation station.As per (b)(4), the fse tested the system and all testing passed.The system is performing to specifications.No defect was found with the navigation station.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 ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23405933
• Report Number: 1526439-2025-01379
• Device Sequence Number: 17378585
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 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: 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: 10/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 12/05/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/03/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RI INCISION TUBE 14; VELYS CAMERA STATION; VELYS ROBOTIC-ASSIST STATION
• Patient Sex: Unknown