BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-HANDLE TORQUE WRENCH 100 IN/LBS, SS

    MDR report key: 2980769 · Received February 27, 2013

    Report

    Report Number
    2027467-2013-00004
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE REVEALED NO ANOMALIES. PERFORMANCE TESTING/CALIBRATION VERIFICATION CONFIRMED THE 100 IN-LBS TORQUE WRENCH CONTINUES TO DELIVER THE REQUIRED AMOUNT OF TORQUE TO SECURELY IMPRISON BOTH THE ROD AND SET SCREWS WITHIN THE ILLICO CONSTRUCT. BOTH THE SURGICAL TECHNIQUE AND INSTRUCTIONS FOR USE PROVIDE DIRECTIONS AND WARNINGS AS TO THE PROPER SET SCREW FINAL TIGHTENING PROCESS. SURGICAL TECHNIQUE LIT-83210 PAGE 14 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. INSTRUCTION FOR USE, INS-028 STATES; WARNINGS: 9. IT IS CRITICAL THAT SET SCREWS ARE TURNED TO THE PROPER TORQUE VALUES AS RECOMMENDED IN THE SURGICAL TECHNIQUES, USING THE INSTRUMENTS PROVIDED. INTRAOPERATIVE MANAGEMENT: 6.THE FINAL OPERATIVE PROCEDURE WITH POLYAXIAL SCREWS MUST INCLUDE TIGHTENING OF SET SCREWS TO 100IN-LB TORQUE VALUE WITH THE INSTRUMENTS PROVIDED. ADDITIONALLY IT WAS REPORTED THAT THE ROD AND THREE SET SCREWS WHICH HAD MIGRATED WERE INSPECTED BY THE OR STAFF WHO DETERMINED THE IMPLANTS TO BE REUSABLE. THE INSTRUCTIONS FOR USE, INS-028 STATE; WARNINGS: 3.THE PRODUCT IMPLANTS ARE SINGLE USE DEVICES. DO NOT REUSE. POSTOPERATIVE MANAGEMENT: 6. RETRIEVED IMPLANTS SHOULD BE PROPERLY DISPOSED OF AND ARE NOT TO BE REUSED UNDER ANY CIRCUMSTANCE. THE ILLICO MIS POSTERIOR FIXATION SYSTEM IS INTENDED TO FACILITATE THE SURGICAL CORRECTION OF NONCERVICAL SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. WHEN USED FOR A MINIMALLY INVASIVE POSTERIOR APPROACH ILLICO MIS INSTRUMENTATION IS USED IN CONJUNCTION WITH POLYAXIAL SCREW COMPONENTS. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (TI-6AL-4V ELI OR TI-6AL-4V). THE RODS ARE AVAILABLE IN COMMERCIALLY PURE (CP) TITANIUM AND/OR COBALT CHROME.

    Description of Event or Problem · 1

    X-RAYS TAKEN DURING A POST-OP VISIT REVEALED 3 OF 6 ILLICO SET SCREWS HAD BECOME LOOSE AND/OR DETACHED FROM THEIR MATING CONSTRUCT WHICH ALLOWED THE ROD TO MIGRATE. THE UNILATERAL LOOSING OCCURRED AT THE L3, L4 AND L5 LOCATIONS. ADDITIONAL INFORMATION PROVIDED REVEALED THAT DURING THE REVISION SURGERY CONDUCTED ON (B)(6) 2013, THE THREE SETS SCREWS AND THE MIGRATING ROD WERE REMOVED FROM THE PATIENT, INSPECTED AND RE-INSTALLED. IMPLANT INSPECTION PERFORMED BY OR STAFF DETERMINED THE IMPLANTS TO BE REUSABLE. X-RAYS TAKEN AFTER THE REVISION SURGERY CONFIRMED BOTH THE ROD AND SET SCREWS TO BE PROPERLY SECURED WITHIN THE ILLICO CONSTRUCT. THE ILLICO MIS POSTERIOR FIXATION SYSTEM WAS ORIGINALLY IMPLANTED IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85420 T-HANDLE TORQUE WRENCH 100 IN/LBS, SS LXH LXH ALPHATEC SPINE INC 73740 6291403-006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention