BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04810

    MDR report key: 3253849 · Received July 30, 2013

    Report

    Report Number
    2520274-2013-04810
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    October 28, 2011
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS PATIENT ID: (B)(6). DEVICE IS AN UNKNOWN SCREW. 510(K) CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ETN PROTECT STUDY REPORTED AN ADVERSE EVENT OF PROXIMAL SCREW BREAKAGE. THE EVENT WAS OF MILD SEVERITY AND DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. THIS REPORT IS ON AN UNKNOWN SCREW. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356276 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention