BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNI

    MDR report key: 2985290 · Received February 26, 2013

    Report

    Report Number
    2520274-2013-10650
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    June 27, 2006
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    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 INFO 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

    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, SPONDYLOLYSIS, AND SPONDYLOLISTHESIS, DEGENERATIVE. PT WAS IMPLANTED WITH A TPLIF SPACER AT LEVELS L4-L5, WITH PEDICLE SCREWS AT L4 AND L5. PT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 3 MONTHS. SURGERY DATE WAS (B)(6) 2006, AND POSTOPERATIVELY PT EXPERIENCED DURAL TEAR, REQUIRING REPAIR WITH SUTURE AND "TESSEL". THIS REPORT IS 11 OF 14 FOR THIS EVENT. THIS REPORT IS ON THE SCREW HEAD AT L4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81201 KNI DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention