BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3139434 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-03008
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 4, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE ADDITIONAL PRODUCT CODES AND COMMON DEVICE NAMES: JEY ¿ BONE PLATE. DEVICE IMPLANTED IN 2011. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR CATALOG NUMBER OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT RECONSTRUCTION WITH THE TITANIUM STERNAL FIXATION SYSTEM IN 2011. IT WAS A DIFFICULT CASE, AS THE PATIENT HAD AN INFECTION PRIOR TO THE RECONSTRUCTION AND WAS A VERY LARGE PATIENT. PATIENT COMPLAINED OF POSTOPERATIVE PAIN. IT WAS NOTED THAT ONE OF THE EMERGENCY PINS CAME OUT OF THE PLATE. THE PLATES AND SCREWS REMAIN IMPLANTED IN THE PATIENT AND SURGEON DOES NOT PLAN TO REVISE PATIENT. REPORTEDLY, THE CONSTRUCT WAS EFFECTIVE FOR THE PATIENT. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241294 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1