BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PLATE 6H HD/4H SHAFT/LEFT

    MDR report key: 3193494 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03820
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT FELL FROM A HORSE ON (B)(6) 2012 AND WAS IMPLANTED WITH PLATES AND SCREWS ON (B)(6) 2012. PATIENT RETURNED TO SURGEON ON AN UNKNOWN DATE COMPLAINING OF PAIN. ON (B)(6) 2013 PATIENT RETURNED TO THE O.R. FOR REMOVAL OF 2 PLATES AND 15 SCREWS. IT IS NOT KNOWN IF PATIENT WAS REVISED TO ANY OTHER HARDWARE. THIS IS 1 OF 17 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294252 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PLATE 6H HD/4H SHAFT/LEFT HRS SYNTHES GMBH 3735905

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention