BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI BROAD LCP PLATE

    MDR report key: 2171338 · Received July 18, 2011

    Report

    Report Number
    8030965-2011-00308
    Event Type
    Injury
    Date Received
    July 18, 2011
    Report Date
    June 22, 2001
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6) INDICATES PATIENT EXPERIENCED A COMPLICATED RIGHT FEMUR SHAFT FRACTURE. PATIENT UNDERWENT AN ORIF PROCEDURE AND WAS IMPLANTED WITH A 4.5MM TI BROAD LCP PLATE AT (B)(6) HOSPITAL. TWO MONTHS POST IMPLANT, PATIENT FELT PAIN AND PRESENTED TO (B)(6) HOSPITAL. AN X-RAY TAKEN SHOWED THE IMPLANT WAS BROKEN. PATIENT WAS REVISED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM TI BROAD LCP PLATE 4.5MM TI BROAD LCP PLATE HRS SYNTHES GMBH NA 2506001

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCREWS