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

Catalog Number	451611000
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
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.Investigation summary: investigation summary: log file analysis has been performed by tpm team, from spineclinicalapp using spine log viewer, based on event date and event description matching the reported information.The 3d images of the procedure have been analyzed, using software clinical application test edition.The investigation confirmed both allegations: wrong level was instrumented by misidentifying spine levels, screw misplacement (planned as l3r but actually l2r).Based on log review, the investigation found that the first issue was due to a use error.The device displayed anatomical landmarks and provided adequate information to correctly label the spine.The second tissue is most likely due to skiving because of the screw planning and/or soft tissue pressure.The device displayed "excessive force" warnings during instrumentation but no corrective actions were then taken to modify the pilot hole trajectory.This issue is linked as well to a use error.The device behave as intended and these issues will continued to be monitored through complaint trending as part of post market surveillance.Root cause: for both issues, the root causes were identified as use errors: misidentification despite anatomical landmarks displayed and available information on the gui.Screw placement despite "excessive force" messages displayed by the system without corrective action taken.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history: no manufacturing record evaluation required as no manufacturer or service related issue found.
Event or Problem Description
It was reported during a l2-s1 fusion procedure the doctor misidentified the levels on the planning screen and they instrumented l1-l5 instead of l2-s1.They did a confirmation spin and found the error so they removed the screws from l1 to place screws at s1.They also found during the spin that the l2 right screw's distal tip was lateral to the vertebral body but ok on pedicle side.They revised the l2 right screw and then placed the s1 screw.The rep stated that neither he nor the local rep saw anything that looked incorrect when they were in the planning screen that would have indicated the plan was on the incorrect levels.Next day of surgery: on (b)(6) 2026.All information has been disclosed.No further information was provided.

• 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: 25153630
• Report Number: 1526439-2026-00551
• Device Sequence Number: 9351460
• Product Code: OLO
• UDI-Device Identifier: 10603295050483
• UDI-Public: (01)10603295050483
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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

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): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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