BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE SELF-DRILLING SCREW - 4.0MM X 16MM, TI

    MDR report key: 2425489 · Received January 23, 2012

    Report

    Report Number
    2027467-2011-00038
    Event Type
    Injury
    Date Received
    January 23, 2012
    Date of Event
    November 15, 2011
    Report Date
    December 28, 2011
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED THE TRESTLE PLATE SCREW INDICATED THE DEVICE WAS PROPERLY MANUFACTURED TO DESIGN SPECIFICATIONS. VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION DETECTED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE IS CURRENTLY BEING CONDUCTED. UPON COMPLETION A FOLLOW-UP SUBMISSION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A TWO LEVEL TRESTLE ANTERIOR PLATING SYSTEM AND SIX SCREWS WERE IMPLANTED IN THE PATIENT ON (B)(6) 2011. ONE MONTH POST-OP X-RAYS (TAKEN (B)(6) 2011) REVEALED ONE OF THE SELF DRILLING SCREWS HAD FRACTURED APPROXIMATELY MID WAY OF THE THREADED SHAFT. ON (B)(6) 2011 - PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE FRACTURED SCREW. THE TOP PROXIMAL SECTION WAS REMOVED WHILE THE BOTTOM THREADED PORTION REMAINS ANCHORED IN THE PATIENTS VERTEBRAE. WHILE RETRIEVING THE TOP SECTION OF THE FRACTURED SCREW, THE SCREW OPPOSITE BECAME DETACHED FROM THE TRESTLE CONSTRUCT AS THE PLATES LOCKING SLIDE WAS SHIFTED. THE SCREW MIGRATED INFERIORLY AND WAS UNABLE TO BE RETRIEVED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIABLE ANGLE SELF-DRILLING SCREW - 4.0MM X 16MM, TI KWQ KWQ ALPHATEC SPINE INC 61240-016 631966

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention