BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APELO PEDICLE SCREWDRIVER

    MDR report key: 1476531 · Received July 7, 2009

    Report

    Report Number
    3003855635-2009-00003
    Event Type
    Malfunction
    Date Received
    July 7, 2009
    Date of Event
    June 3, 2009
    Report Date
    July 7, 2009
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESIGN IMPROVEMENT PROJECT CHANGED MATERIAL TO STRONGER STAINLESS STEEL. FOLLOWING VERIFICATION TESTING, SCREWDRIVERS IN THE APELO SYSTEMS WERE REPLACED WITH NEW SCREWDRIVERS. OLD SCREWDRIVERS WERE DESTROYED.

    Description of Event or Problem · 1

    DOCTOR WAS PLACING THE SECOND SCREW WHEN THE SCREWDRIVER FAILED. DOCTOR OPTED TO SWITCH SYSTEM SO HE REMOVED THE FIRST SCREW. SURGERY WAS DELAYED APPROX 5 MINS; PT WAS UNAFFECTED BY THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APELO PEDICLE SCREWDRIVER PEDICLE SCREWDRIVER HXX ATLAS SPINE INC. 00686

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention