BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 3003536 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10114
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL INSPECTION REVEALED DEVICE BROKEN IN HALF IN DIRECTION OF TEETH AT BOTTOM OF SLOT. BECAUSE OF CONDITION OF COMPONENT ONLY A CALCULATED DIMENSION FOR WALL THICKNESS WAS INSPECTED. ALL RELEVANT DIMENSIONS COULD NOT BE MEASURED. THIS COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LUMBAR FUSION PROCEDURE WHEN THE FINAL TIGHTENING WITH TORQUE WRENCH AND TWO TI COLLARS WITH GROOVES BROKE. ANOTHER TORQUE WRENCH AND COLLARS WERE USED TO COMPLETE THE PROCEDURE. ALL PIECES WERE RETRIEVED. THIS IS REPORT 1 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86226 TI COLLAR WITH GROOVES MNH SYNTHES BRANDYWINE 6546501

    Patients

    Seq Age Sex Outcome Treatment
    1