BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6153706 · Received December 7, 2016

    Report

    Report Number
    3009394448-2016-00009
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 16, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT A DEATH OR LIFE-THREATENING SITUATION. THERE WAS NO SERIOUS INJURY OR DEVICE MALFUNCTION OF ANY KIND REPORTED. HOWEVER, THE MALPOSITIONED IMPLANT DID NOT PERFORM AS INTENDED AND HAD LED TO AN IMPLANT REMOVAL AND REPLACEMENT RE-INTERVENTION. FOR THE PURPOSE OF FULL COMPLIANCE WITH 21 CFR 803, THIS CASE IS REPORTED OUT OF ABUNDANCE OF CAUTION. NOT DEVICE DEFECT RELATED.

    Description of Event or Problem · 1

    A SURGEON PERFORMED A CERVICAL FUSION FOR A PATIENT AND LATER DISCOVERED THROUGH POST-OPERATION X-RAY IMAGES THAT A CAGE WAS MALPOSITIONED INTO THE SOFT TISSUE AREA INSTEAD OF THE INTERVERTEBRAL JOINT AS INTENDED. THE SURGEON DECIDED TO PERFORM A POST-OPERATION REVISION TO REMOVE AND REPLACE THE MALPOSITIONED CAGE. THERE WAS NO DEATH OR SERIOUS INJURY OF ANY KIND REPORTED BEFORE OR AFTER THE REVISION SURGERY. THERE WAS ALSO NO DEVICE MALFUNCTION REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802968 DTRAX CERVICAL CAGE-B DTRAX CERVICAL CAGE-B ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 1182759 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention