BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1810107 · Received August 17, 2010

    Report

    Report Number
    2520274-2010-00152
    Event Type
    Injury
    Date Received
    August 17, 2010
    Report Date
    July 19, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART NUMBER OR LOT NUMBER GIVEN. CANNOT BE DETERMINED WITHOUT PART NUMBER OR LOT NUMBER. NO CONCLUSION CAN BE DRAWN, INVESTIGATION NOT COMPLETED. DEVICE HISTORY RECORD REVIEW CANNOT BE REQUESTED WITHOUT A PART AND LOT NUMBER OF DEVICE.

    Description of Event or Problem · 1

    PT REPORTEDLY HAD AN AO 31C3 FRACTURE OF THE PROXIMAL FEMUR WITH LCP PLATE INSERTED WELL AS PER TECHNIQUE GUIDE. CONICAL SCREWS WERE USED FOR COMPRESSION OF FRAGMENTS AND ALSO TO SEAT PLATE DOWN ON BONE. PT WAS MOBILIZING WITHIN 5 DAYS AND WAS DISCHARGED AT 2 WEEKS. PT WAS RECOMMENDED VIGOROUS THERAPY. PLATE BROKE AT THE SECOND 7.3 MM SCREW HOLE FROM THE PROXIMAL END OF THE PLATE AT APPROXIMATELY 2 MONTHS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PROXIMAL FEMUR PLATE NKB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention CONICAL SCREWS