BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM HEXALOBE SET SCREW

    MDR report key: 1897819 · Received November 12, 2010

    Report

    Report Number
    2027467-2010-00017
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 18, 2010
    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

    THE ACTUAL DEVICES USED THE ORIGINAL SURGERY IS UNKNOWN. MULTIPLE PRODUCTS (SET SCREWS AND TORQUE WRENCHS) WERE RETURNED FROM THE USER FACILITY IN WHICH THE SUSPECT DEVICES ARE KNOWN TO BE COMINGLED. PART NUMBER 22015; TI HEXALOBE SET SCREW: PART NUMBER 62959; T-HANDLE TORQUE WRENCH: LOT NUMBER - 630308 (X1); LOT NUMBER - 5074402 (X1); LOT NUMBER - 622450 (X2); LOT NUMBER - 612285A (X1); LOT NUMBER - 631111 (X3); LOT NUMBER - 630594 (X4). ALL THE PRODUCTS LISTED ABOVE WERE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED TO DESIGN SPECIFICATIONS. ALL MET THE QUALITY INSPECTION PRODUCT RELEASE REQUIREMENTS, NO ANOMALIES WERE FOUND. ADDITIONAL TESTING ON THE T-HANDLE TORQUE WRENCH (B)(4) WAS PERFORMED TO ENSURE BOTH MET THE REQUIRED SPEC VALUE OF 100 - 125 IN/LBS. EIGHT TORQUE SAMPLES ON EACH HANDLE CONFIRMED BOTH DELIVERED THE CORRECT AMOUNT OF TORQUE TO THE SET SCREWS IN QUESTION. CORRESPONDENCE RECEIVED FROM THE SALES REP ON 11/11/10 REVEALED THAT ALL THE SET SCREWS ON ONE SIDE OF THE PATIENT HAD COME LOOSE. ADDITIONALLY. IT WAS STATED THAT HE BELIEVES THE SET SCREWS WERE NOT TORQUED DURING THE INITIAL SURGERY. THE INSTRUCTION FOR USE, INS-025 STATES IN THE WARNING SECTION # 11; 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 PAGE 13 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

    PATIENT UNDER WENT REVISION SURGERY DUE TO LOOSE HARDWARE. IT WAS FOUND THAT THE SET SCREWS ON ONE SIDE OF THE PATIENT HAD COME LOOSE. DATE OF REVISION SURGERY HAS NOT BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention