BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

    MDR report key: 5297507 · Received December 15, 2015

    Report

    Report Number
    2027467-2015-00200
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Report Date
    November 16, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE TRESTLE LUXE SCREWS IS NOT POSSIBLE AT THIS TIME. TWO SEPARATE SCREW PART NUMBERS WERE UTILIZED IN THE CASE, IT IS UNKNOWN WHICH IS FRACTURED AND/OR BACKED OUT. ADDITIONALLY, THE IDENTIFYING LOT NUMBER(S) HAVE NOT BEEN PROVIDED NOR HAVE THE SCREWS BEEN REMOVED FROM THE PATIENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION/DETAILS OF THE EVENT HAVE BEEN UNSUCCESSFUL. TRESTLE LUXE SCREWS UTILIZED IN CASE: 71340-16; 4.0MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 16MM (TI-6AL-4V ELI) ; 71540-14; 4.0MM FIXED ANGLE, SELF-TAPPING HEXALOBE SCREW, 14MM (TI-6AL-4V ELI).

    Description of Event or Problem · 1

    NOTHING OCCURRED INTRA-OPERATIVELY BUT THE PATIENT WAS SEEN ROUGHLY 6 MONTHS POST OP AND THERE'S A BROKEN SCREW AND ANOTHER SCREW BACKING OUT. PATIENT IS OK BUT MAY NEED TO HAVE IT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826367 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other