BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MNI, MNH

    MDR report key: 2963353 · Received February 13, 2013

    Report

    Report Number
    2520274-2013-10016
    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 (B)(4) 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

    IT WAS REPORTED THAT A PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PATIENT WAS IMPLANTED WITH A TPLIF SPACER AT LEVELS L4 L5, L5 S1 WITH PEDICLE SCREWS AT L2, L3, L4, L5 AND S1. PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR ZERO MONTHS. SURGERY DATE WAS (B)(6) 2006 AND POSTOPERATIVELY PATIENT EXPERIENCED DURAL TEAR, REQUIRING SUTURE/TISSEAL GLUE. THIS REPORT IS ON LEFT SCREW AT L4. THIS IS 09 OF 32 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63694 MNI, MNH MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention