BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHATEC TARGETING NEEDLE, TROCAR TIP (STAINLESS STEEL)

    MDR report key: 4925372 · Received July 20, 2015

    Report

    Report Number
    2027467-2015-00153
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. DATE OF EVENT - HAS NOT BEEN PROVIDED AND IS UNKNOWN. LOT NUMBER - HAS NOT BEEN PROVIDED AND IS UNKNOWN. ALTHOUGH THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, PERFORMANCE TESTING WAS CONDUCTED BY THE SUPPLIER OF ALPHATEC TARGETING NEEDLES. TESTING CONSISTED OF ULTIMATE PUSH (INSERTION OF THE DEVICE), ULTIMATE PULL (EXTRACTION OF THE DEVICE IF STUCK), AND ULTIMATE TORSION (TWISTING OF THE DEVICE FOR INSERTION OR EXTRACTION). THE SUPPLIER FOUND THAT DEVICE FUNCTIONS AS INTENDED. NO DISCREPANCIES OR ASSIGNABLE CAUSES WERE DETECTED DURING THEIR ROOT CAUSE INVESTIGATION.

    Description of Event or Problem · 1

    CHALLENGES THE FIELD HAS BEEN EXPERIENCED WITH TARGETING NEEDLES; 1) THE INNER STYLET GETS STUCK IN THE PEDICLE. 2) WHEN THE USER ATTEMPTS TO REMOVE THE OUTER CANNULA WITH THE T-HANDLE, THE HANDLE WILL COME OFF OF THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470220 ALPHATEC TARGETING NEEDLE, TROCAR TIP (STAINLESS STEEL) GAA GAA ALPHATEC SPINE INC 79701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other