BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALENCE ROBOTIC NAVIGATION SYSTEM

    MDR report key: 24990090 · Received April 24, 2026

    Report

    Report Number
    2027467-2026-00015
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    OLO
    UDI-DI
    00190376681177
    PMA / PMN Number
    K252597
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS CONCLUDED.

    Description of Event or Problem · 0

    DURING AN L2-S1 POSTERIOR FIXATION PROCEDURE, THE NAVIGATION SYSTEM INTERMITTENTLY LOST RECOGNITION OF TRACKED INSTRUMENTS AND THE PATIENT ARRAY DESPITE CONTINUED VISUALIZATION OF TRACKING SPHERES. LOSS OF POSITIONAL TRACKING OCCURRED WHILE A PEDICLE SCREW WAS PARTIALLY INSERTED, REQUIRING SCREW REMOVAL AND ROBOTIC REALIGNMENT AFTER TRACKING WAS RESTORED. THIS RESULTED IN A PROCEDURAL DELAY. ONE SCREW WAS REPORTED TO BE PLACED MEDIALLY. POSTOPERATIVELY, THE PATIENT REPORTED LEG PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042013 VALENCE ROBOTIC NAVIGATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ALPHATEC SPINE, INC. 525-400-01 00190376681177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other