BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI CURVED SOFT ROD 85MM

    MDR report key: 2982379 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10103
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 20, 2011
    Report Date
    February 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. DHR REVIEW WAS PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES. VISUAL INSPECTION REVEALED DENTS AND SCRATCHES, MARKS ON BOTH ENDS OF PART AS WELL AS TOP SURFACE. SCRATCHES AND DENTS PRESENT ON DIAMETER. ANODIZE WAS STRIPPED OFF ON TOP AND BOTH SIDES. SURFACE DAMAGE DUE TO FIELD USAGE. RETURNED PART MEETS THE MFG SPECIFICATION FOR THE FEATURES ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED PT 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. PT 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 SYNTHES PANGEA FUSION ROD FROM THE L3-S1 PEDICLE SCREWS WITH THE ROD MIGRATING ROSTRALLY IMPINGING ON THE L2-S1 FACET JOINT. LUMBAR CT SCAN AND LUMBAR FILMS SHOWED DISENGAGEMENT OF THE FUSION ROD FROM THE S1 PEDICLE SCREW AND TIS PROXIMAL MIGRATION. PT UNDERWENT REVISION DECOMPRESSION AND INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L3-S1 FOR SEGMENTAL STABILITY AND RECURRENT SPINAL STENOSIS. THIS IS 1 OF 19 RECORDS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81087 6.0MM TI CURVED SOFT ROD 85MM MNH SYNTHES GMBH 3620807

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention