BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10213

    MDR report key: 3002122 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10213
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    July 10, 2002
    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 ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN (B)(4) STUDY OF 1 OR 2 CONSECUTIVE LEVEL FUSIONS BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OR DBX DEMINERALIZED BONE MATRIX PUTTY WITH AUTOGRAFT. ALL PATIENTS RECEIVED POSTERIOR FIXATION WITH EITHER USS OR CLICK'X SYSTEMS. PATIENT WAS IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 6 MONTHS. SURGERY DATE WAS (B)(6) 2001 AND POSTOPERATIVELY PATIENT EXPERIENCED PAIN, REQUIRING REFERRAL TO PAIN CLINIC. THIS REPORT IS ON THE LOCKING CAP. THIS IS 10 OF 14 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59533 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1