BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6012716 · Received October 7, 2016

    Report

    Report Number
    3009394448-2016-00001
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 7, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT DID NOT RESULT IN DEATH. THERE WAS NO SERIOUS OR LIFE-THREATENING INJURY THAT RESULTED IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR STRUCTURE REPORTED. THERE WAS NO PHYSICAL DEVICE DEFECT OR MALFUNCTION REPORTED IN THIS CASE. ALTHOUGH THERE WAS NO PHYSICAL DEVICE DEFECT OR MALFUNCTION REPORTED IN THIS CASE, THE IMPLANT WAS CONSIDERED "MALFUNCTIONED" BECAUSE IT FAILED TO PERFORM AS INTENDED. THE PERSISTENCE OF SYMPTOMS RESULTED IN A RE-INTERVENTION. IT IS NOTED THAT THERE WERE THREE LOTS OF CERVICAL CAGES USED IN THE PROCEDURE: LOT 1004457 (EXPIRATION ON 4/20/2018), 1176498 (EXPIRATION ON 1/25/2018), AND 1210738 (EXPIRATION ON 4/18/2018). THE FULL PATIENT ID IS (B)(6), WHICH COULD NOT BE ENTERED FULLY IN A PREVIOUS SECTION OF THIS FORM DUE TO SPACE CONSTRAINT. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A SURGEON PERFORMED A CERVICAL FUSION AT C4-C7 ON (B)(6) 2016 USING CERVICAL CAGES. FOLLOWING THE INITIAL SURGERY, THE PATIENT'S SYMPTOMS WERE NOT RESOLVED. THE PATIENT CONSULTED A SECOND SURGEON FOR ANOTHER OPINION. UPON EXAMINATION AND IMAGING STUDIES, THE SECOND SURGEON DETERMINED CAGE PLACEMENT AT C4-C5 WAS TOO MEDIAL AND POTENTIALLY CAUSING NERVE IRRITATION. ON (B)(6) 2016, THE SECOND SURGEON REVISED THE ORIGINAL CERVICAL FUSION BY REMOVING THE INITIALLY PLACED CERVICAL CAGES AND IMPLANTING LATERAL MASS SCREWS AND RODS FROM C4-C7. THE REVISION SURGERY WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663096 DTRAX CERVICAL CAGE-B INTERVETEBRAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 1004457, 1176498, AND 1210738 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention