BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10024

    MDR report key: 2963306 · Received February 13, 2013

    Report

    Report Number
    2520274-2013-10024
    Event Type
    Injury
    Date Received
    February 13, 2013
    Report Date
    January 24, 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 FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING¿ ADDITIONAL CODE IS MNH. 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

    IT WAS REPORTED THAT A PT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PT WAS IMPLANTED WITH A TPLIF SPACER AT LEVELS L4, L5, L5 S1 WITH PEDICLE SCREWS AT L2, L3, L4, L5 AND S1. PT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR ZERO MONTHS. SURGERY DATE WAS (B)(6) 2006 AND POSTOPERATIVELY PT EXPERIENCED DURAL TEAR, REQUIRING SUTURE / TISSEAL GLUE. THIS REPORT IS ON THE SECOND LOCKING CAP AT L3. THIS IS 18 OF 32 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64312 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention