BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP RECONSTRUCTION PLATE 7 HOLES/98MM

    MDR report key: 2121397 · Received June 7, 2011

    Report

    Report Number
    8030965-2011-00272
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    THE 3.5MM LCP RECONSTRUCTION PLATE BROKE 5 WEEKS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI LCP RECONSTRUCTION PLATE 7 HOLES/98MM RECONSTRUCTION PLATE HRS SYNTHES GMBH NA 3550940

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention