BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10211

    MDR report key: 3002134 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10211
    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 (B)(4) 2012. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING...NO SAMPLE WAS RETURNED FOR EVAL. THE LOT NUMBER IS UNK 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

    PT PARTICIPATED IN A (B)(4) OF 1 OR 2 CONSECUTIVE LEVEL FUSIONS BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OR DBX DEMINERALIZED BONE MATRIX PUTTY WITH AUTOGRAFT. ALL PTS RECEIVED POSTERIOR FIXATION WITH EITHER USS OR CLICK'X SYSTEMS. PT WAS IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 6 MONTHS. SURGERY DATE WAS (B)(6) 2001 AND POSTOPERATIVELY PT EXPERIENCED PAIN, REQUIRING REFERRAL TO PAIN CLINIC. THIS REPORT IS ON THE LOCKING CAP. THIS IS 8 OF 14 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60162 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1