BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 3912718 · Received July 3, 2014

    Report

    Report Number
    2520274-2014-12355
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN PLATE/UNKNOWN LOT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARDWARE REMOVAL DUE TO NONUNION OCCURRED. THE INITIAL SURGERY WAS SEVEN YEARS AGO IN (B)(6) AND THE APPLICABLE INFORMATION RELATED TO THE INITIAL SURGERY ARE UNKNOWN. IT WAS ALSO REPORTED, POSTOPERATIVE THAT X-RAYS SHOWED A NON-UNION; ALSO, THE X-RAYS SHOWED THE PROXIMAL FEMUR PLATE WITH UNKNOWN NUMBER OF UNKNOWN SCREWS ARE IMPLANTED AND THEREFORE ATTRIBUTED TO THE NON-UNION. ANOTHER PLATE AND SCREW SYSTEM WAS IMPLANTED; HOWEVER, THERE IS NO ALLEGATION AGAINST THAT SYSTEM. NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME. THIS REPORT IS FOR ONE UNKNOWN PLATE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390144 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention