BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03599

    MDR report key: 3181248 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03599
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    October 5, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    THE SURGEON STATES THAT THERE WAS A DECLINE IN THE DEVICE ANGLE OVER TIME. THIS IS REPORT IS FOR AN UNKNOWN PLATE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282812 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention