BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2983107 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-01230
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    January 30, 2013
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH MATRIX FOR LUMBAR FUSION AT L4-L5. ON (B)(6) 2013 PATIENT WAS RETURNED TO OR TO EXTEND THE LUMBAR FUSION CONSTRUCT TO LEVEL L3-L4 DUE TO ADJACENT LEVEL DISC DISEASE. WHILE REMOVING THE LOCKING CAPS AND RODS AT L4-L5, THE TIP OF THE SCREWDRIVER SHAFT SHEARED OFF. ALL BROKEN FRAGMENTS WERE RETRIEVED; THE SCREWS FOR THE L4-L5 FUSION WERE NOT REMOVED AND REMAIN IMPLANTED. THIS IS 6 OF 11 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85935 SCREW SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention