BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10662

    MDR report key: 2983014 · Received February 26, 2013

    Report

    Report Number
    2520274-2013-10662
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    April 20, 2001
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ADD'L INFO REC'D REGARDING THIS 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

    PT PARTICIPATED IN A (B)(6) STUDY OF 1 OF 2 CONSECUTIVE LEVEL FUSIONS BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OR DBX DEMINERALIZED BONE MATRIX PUTTY WITH AUTOGRAFT. ALL PT'S REC'D POSTERIOR FIXATION WITH EITHER USS OR CLICK'X SYSTEMS. PT WAS IMPLANTED WITH CLICK X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 4 MONTHS. SURGERY DATE WAS (B)(6) 2001 AND POSTOPERATIVELY PT EXPERIENCED A DURAL TEAR, REQUIRING REPAIR DURING SURGERY. THIS REPORT IS ON THE CURVED ROD. THIS COMPLAINT IS 9 OF 14 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81254 MNI

    Patients

    Seq Age Sex Outcome Treatment
    1