BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10230

    MDR report key: 2960507 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10230
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 6, 2001
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNI
    Adverse Event
    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 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 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. ALL PATIENTS RECEIVED POSTERIOR FIXATION WITH EITHER UNIVERSAL SPINAL SYSTEM (USS) OR CLICK'X SYSTEMS. PATIENT WAS IMPLANTED WITH USS FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 10 MONTHS. SURGERY DATE WAS (B)(6) 2001 AND POSTOPERATIVELY PATIENT EXPERIENCED DURAL TEAR, REQUIRING NO TREATMENT. THIS REPORT IS ON THE NUT. THIS IS 13 OF 14 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58569 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention