BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAL DISTRACT BODY 20-36

    MDR report key: 3193275 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03064
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    February 1, 2011
    Manufacturer
    SYNTHES, USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THE DISTRACTOR DIDN'T FIT WELL INTO BLUE ENDPLATE AND FINALLY FELL OUT. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292578 TRANSPAL DISTRACT BODY 20-36 HWC SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1