BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10690

    MDR report key: 2980181 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-10690
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 4, 2007
    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 DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT A PT PARTICIPATED IN A (B)(6) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PT WAS IMPLANTED WITH A TPLIF SPACER AT LEVELS L3L4SIZE & L4L5SIZE WITH PEDICLE SCREWS AT L3, L4 & L5. PT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. THE PT EXPERIENCED PAIN FOR 132 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PT EXPERIENCED INCREASING BACK PAIN DUE TO FALL, REQUIRING PHYSICAL THERAPY AND OVER THE COUNTER ANTI-INFLAMMATORIES. THIS IS 20 OF 20 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78530 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization