BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXRIB UNIVERSAL PLATE 8 HOLES

    MDR report key: 2884424 · Received December 22, 2012

    Report

    Report Number
    8030965-2012-01648
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IN OPERATING ROOM BEING IMPLANTED WITH A MATRIXRIB PLATE AND SCREW CONSTRUCT. DURING THE PROCEDURE, THE SURGEON PLACED THE PLATE BUT EXPERIENCED DIFFICULTY LOCKING THE SCREWS INTO THE PLATE. SURGEON REMOVED THE PLATE AND PLACED A SECOND PLATE, BUT CONTINUED TO EXPERIENCE THE PROBLEM LOCKING THE SCREWS INTO THE PLATE. AT THIS TIME, THE SURGEON FELT THAT THE SCREW/PLATE CONSTRUCT WAS ADEQUATE AND LEFT THE SECOND PLATE IMPLANTED IN PATIENT. SURGEON REUSED THE SAME THREE SCREWS. THIS IS 2 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIXRIB UNIVERSAL PLATE 8 HOLES PLATE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR SCREWS