BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 4043738 · Received August 19, 2014

    Report

    Report Number
    3009394448-2014-00001
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 19, 2014
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY INC.
    Product Code
    ODP
    PMA / PMN Number
    K122801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. MEDICAL EVALUATION OF THE EVENT INDICATES MINIMAL PATIENT RISK WHEN THE MALFUNCTION IS DETECTED INTRA-OPERATIVELY. THE EVENT RESULTED IN NO PATIENT INJURY. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. THE ENTIRE LOT WAS CONTAINED IN-HOUSE WITH ZERO FIELD EXPOSURE AT THE TIME OF THE EVENT. THE CAGE LOADING MANUFACTURING STEPS WERE FOLLOWED WITH NO NONCONFORMANCES. THE CAGE RELEASE SPRING COMPONENT DETACHED DURING THE PROCEDURE WAS CONFIRMED THROUGH RETURNED SAMPLE EVALUATION. INVESTIGATION INDICATED THE MALFUNCTION WAS LIKELY A RESULT OF THE CAGE RELEASE INSTRUMENT BEING OVERSTRESSED.

    Description of Event or Problem · 1

    DURING BILATERAL INSERTION OF CERVICAL CAGE THE SCREW RELEASE MECHANISM DIS-ASSOCIATED WITH THE DELIVERY TOOL, REMAINING ATTACHED TO THE CAGE. AFTER DELIVERY TOOL WAS REMOVED, THE RELEASE MECHANISM COULD BE SEEN STILL ATTACHED. SURGEON USED NEEDLE DRIVERS TO REMOVE THE RELEASE MECHANISM DURING PROCEDURE. NO PATIENT INJURY WAS INDICATED. PATIENT WAS FINE AFTER THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499356 DTRAX CERVICAL CAGE-B CERVICAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY INC. PD-31-200 REV G 927052

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention