BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 5MM

    MDR report key: 3200899 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04026
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING A CRANIOTOMY FOR TUMOR REMOVAL, WHILE THE SURGEON WAS INSERTING THE 5MM MATRIXNEURO SCREWS INTO THE ULTRA LOW PROFILE PLATE, 4 OF THE SCREW HEADS BROKE OFF UPON INSERTION. THE BROKEN SCREWHEADS WERE DISCARDED, THE SHAFTS REMAIN IMPLANTED. THE SURGEON REPOSITIONED THE PLATE SLIGHTLY, AND THEN INSERTED NEW SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM AND NO DELAY TO THE SURGERY. IN ADDITION A SCREWDRIVER BLADE BECAME DAMAGED DURING SCREW INSERTION, AND WILL NOT FUNCTION PROPERLY. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301628 TI MATRIXNEURO SCREW SELF-DRILLING 5MM JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR