BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3031441 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01793
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6). (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DURING TRAUMA SURGERY FOR BURST FRACTURE, SCREWS WERE PLACED POSTERIORLY TWO LEVELS ABOVE AND BELOW FRACTURE. RODS HAD BEEN PLACED AND ALL LOCKING CAPS INSERTED. SURGEON WAS FINAL TORQUE TIGHTENING EACH LOCKING CAP, WORKING HIS WAY FROM THE BOTTOM OF THE CONSTRUCT UP. THE TOP LOCKING SCREW WAS TIGHTENED, HOWEVER, THE DRIVER, 03.632.002, STRIPPED OUT BEFORE FINAL TORQUE HAD BEEN REACHED. HE THEN ATTEMPTED TO REMOVE THE LOCKING CAP WITH A FIXED DRIVER, 03.632.074, HOWEVER, THAT STRIPPED OUT AS WELL. SURGEON FELT THE LOCKING CAP WAS SECURE AND CHOSE TO FINAL TIGHTEN THE REMAINING LOCKING CAPS AND CLOSE THE WOUND. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY TIME AND NO CONSEQUENCE TO THE PATIENT. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134266 TI MATRIX LOCKING CAP NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR