BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHATEC TARGETING NEEDLE, TROCAR TIP (STAINLESS STEEL)

    MDR report key: 4925307 · Received July 20, 2015

    Report

    Report Number
    2027467-2015-00157
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    January 8, 2014
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. 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

    THE INNER STYLE OF THE TARGETING NEEDLE GOT STUCK AND COULD NOT BE TWISTED OFF OR PULLED IT OUT. THE BLUE CANNULA HANDLE BROKE WHILE ATTEMPTING TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470439 ALPHATEC TARGETING NEEDLE, TROCAR TIP (STAINLESS STEEL) GAA GAA ALPHATEC SPINE INC 79701 344914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other