BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6090147 · Received November 9, 2016

    Report

    Report Number
    3009394448-2016-00004
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Product Code
    ODP
    UDI-DI
    00852776006003
    PMA / PMN Number
    K122801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT A DEATH SITUATION. THERE WAS NO LIFE-THREATENING INJURY OR ANY SERIOUS INJURY THAT RESULTED IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR STRUCTURE REPORTED. HOWEVER, THERE WAS ILLNESS IN THE SENSE THAT THE PATIENT EXPERIENCED NEW PAIN AFTER THE ORIGINAL IMPLANTATION DUE TO A MAL-POSITIONED CAGE. THE PAIN LED TO THE RE-INTERVENTION. ALTHOUGH THERE WAS NO DEVICE DEFECT OR MALFUNCTION REPORTED IN THIS CASE, THE MAL-POSITIONED IMPLANT AT C4-C5 LED TO A REVISION 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

    A PATIENT RECEIVED A POSTERIOR CERVICAL FUSION AND EXPERIENCED NEW RIGHT ARM PAIN AFTER SURGERY. THE SURGEON DISCOVERED THROUGH POST-OP CT SCAN EXAMINATION THAT THE CAGE AT C4-C5 WAS PLACED A LITTLE TOO ANTERIORLY. THE PATIENT WAS TAKEN BACK TO THE OR AND RECEIVED A REVISION TO REMOVE THAT CAGE AT C4-C5 WITHOUT REPLACEMENT. IT WAS REPORTED THAT THE PATIENT'S PAIN WAS RESOLVED WITHOUT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741900 DTRAX CERVICAL CAGE-B CERVICAL INTERVERTEBRAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 1037345 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention