BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6090128 · Received November 9, 2016

    Report

    Report Number
    3009394448-2016-00002
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 UNRELIEVED PAIN AFTER THE ORIGINAL PROCEDURE DUE TO POSSIBLE NERVE IMPINGEMENT WHICH MAY RESULT WHEN CAGES WERE NOT LOCATED IN THE INTENDED JOINT SPACE. THE PAIN LED TO THE RE-INTERVENTION. THE PATIENT'S "LARGE FACET" JOINT SPACE AS NOTICED BY THE SURGEON MAY HAVE CONTRIBUTED TO CAGE MOVEMENT LEADING TO "SUBSIDENCE". ALTHOUGH THERE WAS NO DEVICE DEFECT OR MALFUNCTION REPORTED IN THIS CASE, THE "SUBSIDED" IMPLANTS LED TO A REVISION AND THEREFORE FAILED TO PERFORM AS INTENDED. FOR THIS REASON, THIS EVENT WAS REPORTED. NOT DEVICE DEFECT RELATED.

    Description of Event or Problem · 1

    A PATIENT PREVIOUSLY IMPLANTED WITH CERVICAL CAGES FROM C4-T1 WENT THROUGH A REVISION ON (B)(6) 2016 DUE TO RIGHT ARM AND ULNAR PAIN. THE SURGEON DISCOVERED THROUGH POST-OP X-RAY EXAMINATION THAT THREE CAGES HAD SUBSIDED "LATERALLY" AND CAME OUT EASILY WHEN THE SURGEON USED A KOCHER INSTRUMENT TO REMOVE THEM DURING REVISION. THE SURGEON WHO PERFORMED THE REVISION HAD NOTED THAT THIS PATIENT HAS "LARGE FACETS". ALL CAGES FROM C4-T1 WERE REMOVED AND REPLACED WITH HOOK AND ROD FUSION. THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741797 DTRAX CERVICAL CAGE-B CERVICAL INTERVERTEBRAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 1121119 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention