BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 2954981 · Received February 11, 2013

    Report

    Report Number
    2530088-2013-10061
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE MANUFACTURING EVALUATION VISUAL EVALUATION REVEALED THE COLLAR WAS RECEIVED BROKEN AT L2 FEATURE GROOVES. BASED ON THE CONDITION OF THE RETURNED DEVICE, ONLY A CALCULATED WALL THICKNESS WAS MEASURED, AND IS WITHIN TOLERANCE, OTHER RELEVANT FEATURES CANNOT BE VERIFIED; THEREFORE, THE CAUSE IS UNABLE TO BE DETERMINED. PLACEHOLDER.

    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. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED. THE UNIVERSAL SPINE SYSTEM HAS BEEN EXTENSIVELY REVIEWED BASED ON PREVIOUS SIMILAR COMPLAINTS, AND THE DESIGN OF THE COLLAR, NUT, AND SCREW HAS BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE FOR ITS INTENDED USE. IN THIS CASE THE COLLAR IS MOST LIKELY ATTRIBUTED TO THE NUT BEING CROSS THREADED AS IT WAS THREADED ONTO THE SCREW. THIS WOULD MOST LIKELY LOAD THE COLLAR ASYMMETRICALLY AND COULD POTENTIALLY PREVENT THE COLLAR FROM BEING SEATED AS INTENDED. THIS COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT. NO EXPIRATION DATE ORIGINAL AWARENESS DATE IS 06/20/2012. THE DEVICE EVALUATION WAS COMPLETED ON 10/15/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L3-4 POST LUMBAR FUSION PROCEDURE, AS THE PHYSICIAN WAS TIGHTENING THE NUT AND COLLAR ONTO THE SCREW, THE COLLAR POPPED OFF AND SNAPPED. ALL PIECES WERE RETRIEVED. THE PHYSICIAN CHOSE A NEW SCREW AND PARTS TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59113 TI COLLAR WITH GROOVES MNH SYNTHES BRANDYWINE 6807000

    Patients

    Seq Age Sex Outcome Treatment
    1