BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10625

    MDR report key: 2980349 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-10625
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    March 7, 2003
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNI
    Adverse Event
    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

    THE PATIENT PARTICIPATED IN (B)(4) STUDY OF TREATMENT FOR 1 OR 2 CONSECUTIVE LEVEL FUSION BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OR DBX DEMINERALIZED BOX MATRIX PUTTY WITH AUTOGRAFT. ALL PATIENTS RECEIVED POSTERIOR FIXATION WITH EITHER USS OR CLICK'X SYSTEMS. PREOPERATIVE DIAGNOSIS WAS SPONDYLOLISTHESIS, PARS DEFECT. PATIENT WAS IMPLANTED WITH USS FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 12 MONTHS. SURGERY DATE WAS (B)(6) 2003 AND POSTOPERATIVELY PATIENT EXPERIENCED DURAL TEAR AND CSF LEAK, REQUIRING NO TREATMENT. THIS REPORT IS 14 OF 14 FOR THE SAME EVENT. THIS COMPLAINT IS ON THE NUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77358 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention