BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS

    MDR report key: 19230395 · Received May 2, 2024

    Report

    Report Number
    2027467-2024-00047
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 2, 2024
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HXX
    UDI-DI
    00190376473017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE DID NOT RETURN FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED; THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF DEVICE HISTORY RECORDS CANNOT BE PERFORMED. BASED ON THE INFORMATION, THE ROOT CAUSE CANNOT BE DETERMINED. IF THE DEVICE AND/OR ADDITIONAL INFORMATION IS SUPPLIED, A FOLLOW-UP REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: D2. ORTHOPEDIC STEREOTAXIC INSTRUMENT, OLO. D4. MODEL #: 17950-N, CATALOG #: 17950-N, SERIAL #: (B)(6), PRIMARY UDI# (B)(4). D9. YES, RETURNED TO MANUFACTURER ON 05/06/2024. H3. YES. THE DRIVER THAT WAS RETURNED FOR INVESTIGATION WAS A DIFFERENT PART THAN WAS INTIALLY REPORTED. THIS DRIVER DOES NOT REQUIRE AN MDR SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF SYMPTOMS DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458122 INVICTUS SCREWDRIVER HXX ALPHATEC SPINE, INC. 17950-225 00190376473017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown