BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM HEXALOBE SET SCREW, 8.5MM

    MDR report key: 3243446 · Received July 23, 2013

    Report

    Report Number
    2027467-2013-00024
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K100685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICES CANNOT BE PERFORMED AT THIS TIME. THE SET SCREWS HAVE NOT BEEN REMOVED FROM THE PATIENT NOR HAVE THE IDENTIFYING LOT NUMBERS BEEN PROVIDED. LOANER SET (B)(4) WAS RETURNED BY THE SALES REP ON (B)(4) 2013. THE 80 IN-LBS TORQUE WRENCH (P/N 92944, LOT 5955701-016) CONTAINED WITHIN THE SET WAS TESTED TO ENSURE IT PERFORMS AS INTENDED. PERFORMANCE TESTING/CALIBRATION VERIFICATION CONFIRMED THE 80 IN-LBS TORQUE WRENCH CONTINUES TO DELIVER THE REQUIRED AMOUNT OF TORQUE TO SECURELY IMPRISON SET SCREWS WITHIN THE MATING ILIAC SCREW HEAD. THE SUPPLIED INSTRUCTION FOR USE (INS-025) PROVIDES WARNING TO AID IN REDUCING THIS TYPE OF EVENT. IT IS CRITICAL THAT SET SCREWS ARE TURNED TO THE PROPER TORQUE VALUES AS RECOMMENDED IN THE SURGICAL TECHNIQUES, USING THE INSTRUMENTS PROVIDED. THE ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM FACILITATES THE SURGICAL CORRECTION OF SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (TI-6AL-4V ELI OR TI-6AL-4V) OR STAINLESS STEEL. IMPLANT RODS ARE ALSO AVAILABLE IN COMMERCIALLY PURE TITANIUM (TI GRADE 4) AND COBALT CHROME (COCR). ALL HOOKS ARE INTENDED FOR FIXATION/ATTACHMENT TO THE POSTERIOR THORACIC AND LUMBAR SPINE ONLY. IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION.

    Description of Event or Problem · 1

    A PATIENT RETURNED FOR SCHEDULED TWO WEEK POST-OP VISIT ON (B)(6) 2013. X-RAYS TAKEN AT THE TIME REVEALED THE SET SCREWS HAD BECOME DETACHED FROM BOTH ILIAC SCREWS. THERE ARE CURRENTLY NO PLANS FOR REVISION SURGERY. THE ZODIAC HARDWARE WAS IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342442 TITANIUM HEXALOBE SET SCREW, 8.5MM KWP, MNH, MNI KWP ALPHATEC SPINE INC 22085

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other