BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT TRAUMA

    MDR report key: 3133625 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02846
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    LRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. 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. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PLACEHOLDER.

    Description of Event or Problem · 1

    PLATE REDUCTION WIRE WITH OLIVE BROKE DURING PROCEDURE. THIS IS 1 REPORT OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237320 INSTRUMENT TRAUMA LRN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1