BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10292

    MDR report key: 3882999 · Received November 2, 2013

    Report

    Report Number
    2520274-2013-10292
    Event Type
    Malfunction
    Date Received
    November 2, 2013
    Date of Event
    March 1, 2014
    Report Date
    June 10, 2004
    Manufacturer
    SYNTHES (USA)
    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 RECEIVED REGARDING... 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 MULTI-CENTER STUDY OF 1 OR 2 CONSECUTIVE LEVEL FUSIONS BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OF DBX DEMINERALIZED BONE MATRIX PUTTY WITH AUTOGRAFT. ALL PTS RECEIVED POSTERIOR FIXATION WITH EITHER USS OR CLICK'X SYSTEMS. PREOPERATIVE DIAGNOSIS WAS DISK FAILURE OR PROLAPSE. PT WAS IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 10 MONTHS. SURGERY DATE WAS (B)(6) 2003 AND POSTOPERATIVELY PT EXPERIENCED PAIN, REQUIRING PHYSICAL OR OCCUPATIONAL THERAPY. THIS COMPLAINT IS 2 OF 14 FOR THE SAME EVENT; THIS REPORT IS COMPLAINT (B)(4). THIS REPORT IS ON THE CURVED ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565498 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1