BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 7H HD/3H SHFT RT-ST

    MDR report key: 3129210 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02367
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE FOR A DISTAL RADIUS FRACTURE (23-C1), SURGEON REPOSITIONED AND PLACED THE PLATE USING VARIABLE ANGLE POSITIONING. AFTER DRILLING, THE SCREWS WERE INSERTED AND LOCKED INTO EACH HOLE. THE SCREW IN THE DISTAL ROW OF THE MOST ULNA HOLE PENETRATED THE PLATE. A TORQUE LIMITER WAS USED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231761 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 7H HD/3H SHFT RT-ST PLATE, FIXATION, BONE HRS SYNTHES GMBH 8022937

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR