BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMACEM CEMENT KIT

    MDR report key: 3161944 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03295
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    January 5, 2010
    Report Date
    May 16, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AUGMENTED PFNA, 1ST MPE, EXCHANGE OF SHORT PFNA TO LONG NAIL, POST JOINT SPACE PERFORATION THERE WAS CEMENT LEAKAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263015 TRAUMACEM CEMENT KIT NDN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention