BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MMTI PANGEA (TM) POLYAXIAL

    MDR report key: 2982382 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10105
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    February 23, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DHR REVIEW WAS PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. POLYAXIAL ASSEMBLY COMPOSITION WAS CONFIRMED USING A MATERIAL ANALYZER. HOWEVER NOT ALL THE INDIVIDUAL COMPONENTS COULD BE ANALYZED SEPARATELY. BASED ON DHR REVIEW AND INVESTIGATION RESULTS THIS COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT L3 TO S1 POSTERIOR INSTRUMENTED FUSION USING SYNTHES PANGEA PEDICLE SCREW SYSTEM TO TREAT RECURRENT SPINAL STENOSIS IN THE SETTING OF POSTLAMINECTOMY SYNDROME AND POSTLAMINECTOMY INSTABILITY ON (B)(6) 2011. PATIENT DID WELL INITIALLY BUT STARTED TO COMPLAIN OF ONSET OF LOW BACK AND LEFT LEG PAIN 6 WEEKS FOLLOWING THE SPINAL FUSION. WORK UP SHOWED DISENGAGEMENT OF THE LEFT SIDED L1-S1 PEDICLE SCREWS WITH THE ROD MIGRATING ROSTRALLY IMPINGING ON THE L2-L3 FACET JOINT. LUMBAR CT SCAN AND LUMBAR FILMS SHOWED DISENGAGEMENT OF THE FUSION ROD FROM THE S1 PEDICLE SCREW AND ITS PROXIMAL MIGRATION. PATIENT UNDERWENT REVISION DECOMPRESSION AND INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L3-S1 FOR SEGMENTAL INSTABILITY AND RECURRENT SPINAL STENOSIS. THIS IS 4 OF 19 RECORDS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81042 6.0MMTI PANGEA (TM) POLYAXIAL NKB SYNTHES BRANDYWINE 6477472

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention