BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6123171 · Received November 22, 2016

    Report

    Report Number
    3009394448-2016-00008
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    December 18, 2016
    Report Date
    December 19, 2016
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Product Code
    ODP
    UDI-DI
    00852776006003
    PMA / PMN Number
    K122801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT A DEATH OR LIFE-THREATENING SITUATION. THERE WAS NO SERIOUS INJURY THAT RESULTED IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR STRUCTURE REPORTED. HOWEVER, THERE WAS ILLNESS IN THE SENSE THAT THE PATIENT EXPERIENCED POST-OP PAIN IN THE RIGHT HAND AND THUMB AFTER THE ORIGINAL IMPLANTATION DUE TO A MAL-POSITIONED CAGE PLACED TOO MEDIALLY. THE PAIN LED TO THE RE-INTERVENTION. ALTHOUGH THERE WAS NO DEVICE DEFECT OR MALFUNCTION CONTRIBUTED TO THIS CASE, THE MAL-POSITIONED IMPLANT AT C5-C6 LED TO A RE-INTERVENTION AND THEREFORE FAILED TO PERFORM AS INTENDED. FOR THIS REASON, THIS EVENT WAS REPORTED TO FULLY COMPLY WITH 21 CFR 803. NOT DEVICE DEFECT RELATED.

    Description of Event or Problem · 1

    PATIENT RECEIVED A C5-C7 CERVICAL FUSION TO TREAT A PREVIOUSLY FAILED ACDF FUSION AT THE SAME LEVELS. PATIENT WOKE UP AFTER THE SURGERY WITH NUMBNESS AND PAIN IN THE RIGHT HAND AND THUMB. THE SURGEON TOOK A POST-OP CT SCAN AND DETERMINED THAT AN IMPLANT WAS PLACED TOO MEDIALLY WHICH COULD CONTRIBUTE TO THE PAIN. THE SURGEON DECIDED TO PERFORM A REVISION TO REMOVE THE CAGE AT C5-C6. THE PATIENT DID NOT REPORT ANY FURTHER OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS NO DEVICE MALFUNCTION IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773199 DTRAX CERVICAL CAGE-B PD-31-200 ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 1108924 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention