BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 2945375 · Received February 1, 2013

    Report

    Report Number
    2530088-2013-10015
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SURGEON COMPLETED A LUMBAR FUSION FROM L1-ILIUM FOR A PT WITH MILD DEFORMITY. IMPLANTS WERE CONNECTED, LOCKING CAPS PLACED AND TIGHTENED DOWN. AN ANTERO POSTERIOR VIEW WITH FLUORO WAS TAKEN AND SURGEON DECIDED TO PERFORM A COMPRESSION/DISTRACTION TO REDUCE DEFORMITY. AS SURGEON BEGAN TO DISASSEMBLE THE CONSTRUCT, THREE LOCKING CAPS WERE DIFFICULT TO LOOSEN. THE LOCKING CAP AT L1 WOULD NOT LOOSEN. IN AN ATTEMPT TO REMOVE THE LOCKING CAP, THE TIP OF THE T25 STARDRIVE SHAFT BROKE OFF IN THE LOCKING CAP. THE LOCKING CAP WAS REPLACED AND SURGEON COMPLETED DISTRACTION AND COMPRESSION. THE OTHER TWO LOCKING CAPS WERE RE-TIGHTENED. PROCEDURE WAS EXTENDED BY AN ADDITIONAL 10 MINUTES. AFTER THE PROCEDURE SALES CONSULTANT NOTICED THAT THREE OF THE SCREWDRIVERS USED DURING THE PROCEDURE WERE DAMAGED. THE TIP ON ONE OF THE T25 STARDRIVE SHAFTS WAS DEFORMED. ALSO NOTED, THE TIP OF ONE OF THE T25 STARDRIVE SHAFT-LONG WAS STRIPPED AND THE TIP ON THE OTHER T25 STARDRIVE SHAFT-LONG WAS DISCOLORED AND MAY HAVE BEEN WEAKENED FROM THE PROCEDURE. THIS COMPLAINT PERTAINS TO THE SECOND LOCKING CAP THAT WAS RE-TIGHTENED. THIS REPORT IS THREE OF SEVEN FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44496 TI MATRIX LOCKING CAP NKB SYNTHES (USA) BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1