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

Catalog Number	451611001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 t4 to l1 posterior spinal fusion procedure, during screw the surgeon deemed that the phantom was inaccurate when t7 and t8 on the left side were lateral to plan.A second spin was completed and when they placed the rest of the screws in the segment, 4 of the screws were considered inaccurate to plan: t6 was lateral on left side, t5 on the right side was deemed medial, t7 on right side was deemed medial and t8 on the right side was deemed medial.Some screws were replaced with free hand navigation and others were not in the spin were completed free hand without navigation.Robot was on the patient's right side.There was patient involvement, but no injuries, medical intervention, or prolonged hospitalization were reported.
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: added: d10 (concomitant).H3, h6: investigation summary: according to the information received, the issue with the following product: 451611001 sn (b)(6).Upon registration of the patient - then the surgeon deemed that the phantom was inaccurate when t7 and t8 on the left side were lateral to plan.A second spin was completed and when they placed the rest of the screws in the segment, 4 of the screws were considered inaccurate to plan: t6 was lateral on left side, t5 on the right side was deemed medial, t7 on right side was deemed medial and t8 on the right side was deemed medial.Results received from the engineering team: (uploaded under velys navigation station (b)(4)).Investigation summary: the investigation was conducted by tpm team.The reported issue could not be confirmed for velys robotic-assist station.The issue is related to velys navigation station software.Log review confirmed the device captured a registration mismatch followed by the request to perform an anatomy check step, as defined in this situation.Further log review investigation is under the velys navigation station (b)(4).Root cause: no failure found with the velys robotic-assist station.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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 ROBOTIC-ASSIST 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 33410
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23923484
• Report Number: 1526439-2025-01832
• Device Sequence Number: 8763626
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• UDI-Public: (01)10705034646008
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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

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: 451611001
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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: VELYS CAMERA STATION.; VELYS CAMERA STATION.; VELYS SPINE ARRAY BASE SET.
• Patient Sex: Unknown