BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10942

    MDR report key: 3003554 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10942
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 20, 2002
    Report Date
    February 20, 2002
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF 1 OR 2 CONSECUTIVE LEVEL FUSIONS BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OR DBX DEMINERALIZED BONE MATRIX PUTTY WITH AUTOGRAFT. PATIENT WAS IMPLANTED WITH CLICK'X FOR SUPPLEMENTAL FIXATION. POSTOPERATIVELY, PATIENT EXPERIENCED PAIN REQUIRING REFERRAL TO A PAIN CLINIC. THIS IS REPORT 14 OF 14 FOR THIS EVENT. THIS REPORT IS ON THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86229 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR