BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/4H SHAFT/LEFT

    MDR report key: 2904210 · Received January 9, 2013

    Report

    Report Number
    8030965-2013-00070
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A DISTAL RADIUS FRACTURE TREATMENT. IT WAS REPORTED THAT 2 WEEKS POST REPAIR, WHEN THE PATIENT WAS EXAMINED BY THE SURGEON, THE EXAM AND X-RAY REVEALED THAT THE FRACTURE WAS NOT HEALING AS THE SURGEON INTENDED. THE SURGEON RETURNED THE PATIENT TO THE OPERATING ROOM ON (B)(6) 2012 AND EXPLANTED THE PLATE AND AN UNKNOWN NUMBER OF LOCKING AND CORTEX SCREWS. THE SURGEON THEN REPOSITIONED AND RE-REDUCED THE FRACTURE. THE ORIGINAL PLATE AND AN UNKNOWN NUMBER OR TYPE OF THE ORIGINAL SCREWS WERE RE-IMPLANTED AND AN UNKNOWN NUMBER OR TYPE OF NEW SCREWS ADDED. IN ADDITION, THE SURGEON IMPLANTED A DORSAL PLATE TO AID IN STABILITY OF THE FRACTURE. THIS IS REPORT #1 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11637 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/4H SHAFT/LEFT DISTAL RADIUS PLATE HRS SYNTHES GMBH 3102438

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention