BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP MEDIAL DISTAL TIBIA PLATE

    MDR report key: 1111015 · Received August 12, 2008

    Report

    Report Number
    3003506883-2008-00013
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K013248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L NARRATIVE: ADD'L INFO HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A 3.5MM LCP MEDIAL DISTAL TIBIA PLATE BROKE POSTOPERATIVELY. BREAKAGE OCCURRED NEAR THE CONTOUR OF THE PLATE AND 2 SCREW HOLES. SCREWS WERE NOT IMPLANTED IN THE HOLES WHERE THE BREAKAGE WAS NOTED. PLATE AND SCREWS WERE REMOVED AND REPLACED WITH A TIBIAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP MEDIAL DISTAL TIBIA PLATE MEDIAL DISTAL TIBIA PLATES HRS SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention SCREWS