BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-05020

    MDR report key: 3310763 · Received August 27, 2013

    Report

    Report Number
    2520274-2013-05020
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    A JOURNAL ABSTRACT WAS RECEIVED TITLED: INTRAPELVIC MIGRATION OF A GUIDE PIN DURING FIXATION OF A HIP FRACTURE: WHO AND WHAT IS TO BLAME? ACTA ORTHOPAEDICA BELGICA. APRIL 2005; 71 (2):239-241. AUTHORS AND WEBSITE: SAYEGH F.E., TSINTZAS D., KAPETANOS G.A. REPORTEDLY A (B)(6) PATIENT UNDERWENT INTERNAL FIXATION WITH A DYNAMIC HIP SCREW FOR A STABLE INTERTROCHANTERIC FRACTURE OF THE RIGHT HIP ON AN UNKNOWN DATE. THERE WAS A COMPLETE INTRAPELVIC MIGRATION OF THE THREADED GUIDE PIN NOTED IN THE POSTOPERATIVE RADIOGRAPH, WHICH WAS NOT NOTICED DURING THE OPERATION. BY LAPAROTOMY, THE PIN WAS REMOVED WITH NO DAMAGE TO THE PELVIC VISCERA REPORTED. THE PATIENT REPORTEDLY MADE AN UNEVENTFUL RECOVERY. A COPY OF THE LITERATURE ABSTRACT IS BEING SUBMITTED WITH THIS REPORT. THIS REPORT IS FOR A GUIDE PIN/WIRE. IT IS UNKNOWN IF THE DEVICE IS A SYNTHES PRODUCT. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419050 FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR