BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP RECONSTRUCTION PLATE 6 HOLES/84MM

    MDR report key: 2032601 · Received March 23, 2011

    Report

    Report Number
    8030965-2011-00092
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6), INDICATES A PT WAS IMPLANTED WITH A 3.5MM TI LCP RECONSTRUCTION PLATE, 6 HOLES/84MM. POST OPERATIVELY PLATE WAS NOTED AS BROKEN AND WAS REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI LCP RECONSTRUCTION PLATE 6 HOLES/84MM TI LCP RECONSTRUCTION PLATE HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS