BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT

    MDR report key: 3192583 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03829
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2013 FOR A NON-UNION OF THE PROXIMAL FEMUR. THREE UNKNOWN 5.0MM LOCKING SCREWS, ONE UNKNOWN 5.0MM CANNULATED LOCKING SCREW, TWO UNKNOWN 7.3MM CANNULATED LOCKING SCREWS, AND ONE 4.5MM LCP PROXIMAL FEMUR PLATE WERE REMOVED. THE ORIGINAL IMPLANT WAS ON (B)(6) 2013. PATIENT WAS REVISED TO AN ANGLED BLADE PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292317 4.5MM LCP® PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention