BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10064

    MDR report key: 2960787 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10064
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    May 31, 2007
    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. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE. PATIENT WAS IMPLANTED WITH A TPLIF SPACER AT LEVELS L5S1SIZE, WITH PEDICLE SCREWS AT L5 AND S1. PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 11 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PATIENT EXPERIENCED LEFT ANKLE PAIN LEFT LEG AND FOOT SWELLING, REQUIRING EPIDURAL STEROID INJECTION AT L5-S1. THIS COMPLAINT IS ON THE RIGHT SCREW AT L5. THIS IS REPORT 6 OF 14 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60037 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention