BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP-DF 4.5/5 LE 11HO L276 TAN

    MDR report key: 2211274 · Received August 5, 2011

    Report

    Report Number
    8030965-2011-00530
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SERVICE. THE MFG RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ANALYSIS COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORTED FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED: PT STATUS POST TI LCP DISTAL FEMUR PLATE IMPLANTATION ON AN UNK DATE WAS DISCOVERED TO HAVE A BROKEN PLATE. ALL SCREWS WERE INTACT AND MEDICAL/SURGICAL INTERVENTION WAS NEEDED. DATE OF REMOVAL IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP-DF 4.5/5 LE 11HO L276 TAN : TI LCP DISTAL FEMUR PLATE HRS SYNTHES GMBH 2356123

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW