BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 2983009 · Received February 26, 2013

    Report

    Report Number
    1719045-2013-10074
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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

    IT WAS REPORTED DURING A MINIMAL INVASIVE DISCECTOMY PROCEDURE AN UNIDENTIFIED OBJECT FELL OUT OF THE FLEX ARM. IT WAS CONFIRMED THAT THE OBJECT DID NOT FALL INTO PT. IT WAS BELIEVED THE OBJECT WAS DRIED BLOOD, BUT WHEN TESTED IT WAS DETERMINED NOT TO BE. ANOTHER FLEX ARM WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81252 FLEX ARM LXH SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1