BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES USA

    MDR report key: 65366 · Received December 23, 1996

    Report

    Report Number
    65366
    Event Type
    Injury
    Date Received
    December 23, 1996
    Date of Event
    May 14, 1996
    Report Date
    August 21, 1996
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SEVERAL MONTHS POST ORIF OF AN INTERTROCHANTERIC HIP FRACTURE ON L SIDE. SURGICAL REPAIR PERFORMED ON 2/17/96. POST-OP PT DEVELOPED NON-UNION OF FRACTURE WITH CUTTING OUT OF THE FEMORAL SCREW. DUE TO PAIN SURGICAL REMOVAL OF THE IMPLANTS WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA Implant BONE PLATE HRS SYNTHES USA UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention DHS SCREWS USED TO SECURE PLATE