BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10522

    MDR report key: 2980363 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-10522
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    April 28, 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

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THIS PT PARTICIPATED IN A (B)(4) OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. THE PT WAS IMPLANTED WITH A TRANSFORMATIVE POSTERIOR LUMBER INTERBODY FUSION (TPLIF) SPACER AT LEVELS L4 AND L5, AND PEDICLE SCREWS AT L3 AND L4. THE PT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. POSTOPERATIVELY, THE PT EXPERIENCED A DURAL TEAR, REQUIRING REPAIR WITH SILK STITCH AND TISSUE GLUE. THIS COMPLAINT IS ON THE CURVED ROD. THIS IS REPORT 1 OF 14 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77443 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention