BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE

    MDR report key: 3003393 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10253
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    April 14, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, BUBBLES ON BOTTOM OF GRAPHIC CASES CAUSE HOLES IN BLUE STERILIZATION WRAP WHEN STERILIZED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86980 GRAPHIC CASE LXH SYNTHES (USA) MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1