BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE CALCNL 3.5 X 6H/70MM 245.16

    MDR report key: 4905685 · Received July 6, 2015

    Report

    Report Number
    MW5043903
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    October 13, 2013
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT INVOLVED IN LEVEL ONE MVA. MULTIPLE TRAUMATIC INJURIES INCLUDING FRACTURED CLAVICLE. INITIAL PLATE BENT IN HALF AT 90 DEGREE ANGLE IN FIRST 5 DAYS IN HOSPITAL. HAD TO BE REMOVED AND REPLACED 10 DAYS LATER. NOW, LONG TERM EFFECTS OF DOWN ROM, NUMBNESS, TINGLING AND WEAKNESS IN SHOULDER AREA AND PAIN IN POSTERIOR NECK. WRONG SIZE AND TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436477 PLATE CALCNL 3.5 X 6H/70MM 245.16 SYNTHES CLAVICLE PLATE HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| O| R| S