BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 444271 · Received January 17, 2003

    Report

    Report Number
    2520274-2003-00005
    Event Type
    Injury
    Date Received
    January 17, 2003
    Date of Event
    December 16, 2002
    Report Date
    January 17, 2003
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LARGE LOCKING PLATE IMPLANTED IN 2002 BROKE POST-OPERATIVELY 8 MONTHS LATER. SURGEON INDICATED THAT PLATE BROKE WHEN PT WAS CLIMBING BLEACHERS AND FELL OFF. 2003 - RETURNED QUESTIONNAIRE INCLUDED THE FOLLOWING INFO: PT WITH IMPENDING R DISTAL FEMUR FRACTURE TREATED WITH CURETTAGE/CEMENT AND LATERAL LOCKING PLATE IN 2002. WB AT POST-OP BUT DEVELOPED SPIRAL FEMUR FRACTURE PROXIMAL TO CEMENT EXTENDING TO PROXIMAL DIAPHYSIS IN 3/02. THIS WAS TREATED WITH ANTERIOR PLATE FIXATION. THE PT WAS NWB FOR 6 MONTHS, THEN PARTIAL WB FOR 6-8 WEEKS. DEVELOPED PLATE FAILURE, UNDERWENT "RESERTION" OF PLATE AND DISTAL FEMUR IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK HRS SYNTHES (USA) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCREWS