BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM HEXALOBE SET SCREW

    MDR report key: 2070582 · Received April 27, 2011

    Report

    Report Number
    2027467-2011-00005
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K033090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OF THE SIX SUSPECT DEVICES WERE RETURNED FOR AN EVALUATION. THE REMAINING FOUR WERE INADVERTENTLY DISCARDED BY THE USER FACILITY. THE EVALUATION CONCLUDED THE SET SCREWS WERE PROPERLY MANUFACTURED TO DESIGN SPECIFICATION AND PERFORM AS INTENDED. NO IRREGULARITY WAS DETECTED. CORRESPONDENCE FROM THE SALES REP REVEALED THE SURGEON BELIEVES THE SET SCREWS WERE NOT TORQUED DURING THE INITIAL SURGERY. HE HAS NO CONCERNS WITH THE ZODIAC SPINAL FIXATION SYSTEM. THE INSTRUCTION FOR USE, INS-025 STATES; IT IS CRITICAL THAT SET SCREWS ARE TURNED TO THE PROPER TORQUE VALUES AS RECOMMENDED IN THE SURGICAL TECHNIQUES, USING THE INSTRUMENTS PROVIDED. SURGICAL TECHNIQUE LIT-83065 INSTRUCTS THE USER TO UTILIZE THE SUPPLIED 100 IN/LB TORQUE WRENCH. TURN THE T-HANDLE CLOCKWISE. FINAL TIGHTENING IS ACHIEVED WHEN THE T-HANDLE AUDIBLY CLICKS.

    Description of Event or Problem · 1

    X-RAYS TAKEN DURING A POST-OP VISIT REVEALED 4 OF 6 ZODIAC SET SCREW HAD BECOME DETACHED FROM THEIR MATING CONSTRUCT. REVISION SURGERY CONDUCTED ON (B)(6) 2011 TO REMOVE AND REPLACE THE SET SCREWS DISCOVERED THE REMAINING TWO WERE LOOSE. THE ZODIAC SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM HEXALOBE SET SCREW KWP, MIN, MNH KWP ALPHATEC SPINE INC 22015 637383

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention