BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10183

    MDR report key: 2960747 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10183
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    August 21, 2006
    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 A FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) 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

    PT PARTICIPATED IN A (B)(4) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE. PT WAS IMPLANTED WITH A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) SPACER AT LEVELS L5 S1 WITH PEDICLE SCREWS AT L5 AND S1. PT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 36 MONTHS. SURGERY DATE WAS (B)(6) 2006 AND POSTOPERATIVELY PT EXPERIENCED DURAL TEAR, REQUIRING REPAIR. COMPLAINT #8 OF 14. THIS COMPLAINT IS ON THE LOCKING CAP AT S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59912 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention