BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10071

    MDR report key: 2960762 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10071
    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 A FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED IN 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 NOT PRODUCT WAS 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 TPLIF SPACER AT LEVELS L5 S1 SIZE, WITH PEDICLE SCREWS AT L5 AND S1. PT WAS IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 11 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PT EXPERIENCED LEFT ANKLE PAIN, LEFT LEG AND FOOT SWELLING, REQUIRING EPIDURAL STEROID INJECTION AT L5-S1. THIS COMPLAINT IS ON THE SCREW HEAD AT L5. THIS IS REPORT 13 OF 14 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59957 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention