BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING COMPRESSION PLATE NARROW AXSOS 10 HOLE/L

    MDR report key: 1211122 · Received October 23, 2008

    Report

    Report Number
    8031020-2008-00097
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    May 8, 2008
    Report Date
    September 29, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K060514
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, A FEMALE PATIENT WHO RECEIVED IMPLANTATION OF FEMUR LOCKED PLATE IN 2008, PRESENTS PLATE FRACTURE DURING RECOVERY. RECEIVES SECOND SURGERY AT APPROXIMATELY FOUR MONTHS LATER, WHERE BROKEN PLATE IS REMOVED, AND NAIL IS INSERTED (NOT STRYKER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING COMPRESSION PLATE NARROW AXSOS 10 HOLE/L IMPLANT HRS STRYKER OSTEOSYNTHESIS SELZACH UNK N10674

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention