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	Nerve Damage (1979)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
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 the patient underwent a l4-l5 a tlif procedure with mis prime screws on first side and facet screws on the opposite side.The surgeon put the two pedicle screws on one side first, then the cage and lastly the set screw on the other side.Surgeon did the viper prime without issue and completed the spin, completed registration.Following registration, system requested anatomy check ¿ surgeon performed anatomy check and stated it was acceptable.When they reached the point where they were ready to send the robot arm to the trajectory ¿ warning received¿ patient tracker angle and l4 screw would be a collision.Patient array was located on the psis right side.They adjusted the angle of the screws more laterally and at this point the doctor bumped the patient array.They went to the first trajectory, put the core down, brought in the 5mm acorn bit, rep recommended making a knocking point.The doctor went down and the patient moved, described as they bucked like they were in pain.The doctor put the screw in and it was testing at a 7.They brought in the x-ray and found the screw was medialized.They changed the trajectory of the screw and it was testing at an 8.They moved to l5 and it was testing above a 20.After putting the cage in, they did another spin and they saw that both screws were medialized.They saw that half the screws were in the bone and the other half were in the core.Both screws were off by the same amount.The rep found out post-op after a discussion between the doctor and the pa that the doctor had bumped the patient array.The patient lost the quads initially but they came back after they replaced the screws.The rep received an update that the patient is awake and doing well on (b)(6) 2025.Patient treatment was not delayed or cancelled.Next day of surgery: (b)(6) 2025.It was further reported that 1 facet screw was placed and all viper screws were placed through the robot arm.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 and 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: h3, h6: investigation summary: according to the information received, the issue with the following product: 451611000 sn (b)(6).L4-l5 alif procedure.The doctor puts the two pedicle screws on one side first, then the cage and lastly the set screw on the other side.Did the viper prime without issue and completed the spin, completed registration, they started planning the screws.The location of the patient array was causing the robot to notify that there may be a potential collision.Patient array was located on the psis right side.They adjusted the angle of the screws more laterally and at this point the doctor bumped the patient array.They went to the first trajectory, put the core down, brought in the 5mm acorn bit, rep recommended making a knocking point.The doctor went down and the patient moved, described as they bucked like they were in pain.The doctor put the screw in and it was testing at a 7.They brought in the x-ray and found the screw was medialized.They changed the trajectory of the screw and it was testing at an 8.They moved to l5 and it was testing above a 20.After putting the cage in, they did another spin and they saw that both screws were medialized.They saw that half the screws were in the bone and the other half were in the core.Both screws were off by the same amount.The rep found out post-op after a discussion between the doctor and the pa that the doctor had bumped the patient array.The patient lost the quads initially but they came back after they replaced the screws.The rep received an update that the patient is awake and doing well on (b)(6) 2025.Investigation summary: the investigation confirmed the described issues.This issue was investigated and reviewed by the system and tpm team.Issue #1 the investigation showed that as the robot arm aligned with the planned implant trajectory and potential collision was detected while no actual collision occurred.The arm motion stopped, and the user was notified.For this issue, there were no defects found with the system and software.The reporter indicated that there was no negative impact to the patient outcome related to this issue and the investigation indicates that the system was behaving properly.Issue #2 the investigation showed that there were multiple confirmed use errors related to potential motion of the patient array and accepting an inaccurate image to patient registration after performing an insufficient and inappropriate anatomy check.As such, the issue #2 is deemed due to user errors.Each of these use error conflicts with instructions in the ifu with details below: 1.A registration mismatch accepted through inadequate anatomy check (i.E.That did not check the anatomical surfaces as directed by the ifu (090260229 rev d)).A.See page 180 of the ifu -- "in the case of failure of an anatomy check: restart the procedure using the toolbox and acquire a new 3d image or convert to a conventional procedure." 2.Attempting to work around an known inaccurate registration by "adjusting" the plan incorrectly to compensate for the registration.A.This use error is an intentional decision to proceed in a manner inconsistent with labeling on page 180 of the ifu 3.Motion of the patient tracking array post registration.A.See page 148 of the ifu.Patient array must be securely fixed to the patient¿s bony anatomy using the indicated methods referenced above.Any loss of fixation will result in loss of accuracy of the device.B.And page 152 of the ifu.Movement of the patient array will compromise the accuracy of the system.Be careful to avoid any contact with the patient array throughout the procedure.If there has been possible movement of the patient array, perform an anatomy check.4.Excessive force on the arm during instrument use.A.See page 253 of the ifu.The robotic arm undergoes too much external force while velys¿ adaptive tracking¿ is running.Make sure there is no soft tissue pressure on the tool holder or no instrument skiving.The reporter indicated in follow-up information the patient was "doing well" and the investigation indicates that the system was behaving properly.For this issue, there were no defects found with the system and software.These issues will be continued to be monitored through complaint trending as part of post market surveillance.Root cause: issue #1: no issue found.Issue #2: use error.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 report, a follow-up report 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 33410
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23353489
• Report Number: 1526439-2025-01329
• Device Sequence Number: 9131120
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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?: Yes
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 11/25/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/31/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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 ROBOTIC-ASSIST STATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown