BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX SCREW

    MDR report key: 3003403 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10208
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    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. THE MANUFACTURING INVESTIGATION REVEALED THE LOCKING THREADS LOCATED ON THEIR ID OF THE HEAD OF THE SCREW ARE PARTIALLY BROKEN AWAY FROM THE SCREW. THE STARDRIVE SHOWS SOME MARKS NOT CONSISTENT WITH MANUFACTURING. DUE TO THE THREAD OF THE SCREW BEING PARTIALLY BROKEN OFF, IT IS CONCLUDED THE DIMENSIONS PERTINENT TO THE COMPLAINT COULD NOT BE EVALUATED. THEREFORE, THIS COMPLAINT IS CONSIDERED INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING L4-L5-S1 LUMBAR FUSION PROCEDURE, THE THREADS AND SCREW HEADS OF SCREW WERE DAMAGED. THE SURGEON ASSEMBLED THE THREADED DISTRACTOR SLEEVE WITH THE SCREWS, THEN PLACED THE DISTRACTOR IN THE SLEEVE, AND UPON DISTRACTION, THE THREADS PULLED AWAY ON ALL THE SCREWS, AND DEFORMED THE SCREW HEADS. THE SURGEON EXPLANTED ALL 4 SCREWS, AND THEN WAS ABLE TO COMPLETE THE PROCEDURE WITH 4 NEW SCREWS, AND A DIFFERENT DISTRACTOR SLEEVE WITH NO FURTHER PROBLEM. NO FRAGMENTS REMAINED IN THE PATIENT. THIS REPORT IS ON THE MATRIX SCREW. THIS IS REPORT 3 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86771 6.0MM TI MATRIX SCREW NKB SYNTHES (USA) BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR