BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6178292 · Received December 15, 2016

    Report

    Report Number
    3009394448-2016-00010
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    February 13, 2015
    Report Date
    February 26, 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
    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 NEW POST-OPERATION PAIN EXPERIENCED BY THE PATIENT LIKELY DUE TO IMPLANT MIGRATION DURING FUSION RESULTED FROM THE PATIENT'S ACTIVE LIFESTYLE. THE PAIN LED TO THE RE-INTERVENTION. ALTHOUGH THERE WAS NO DEVICE DEFECT OR MALFUNCTION REPORTED IN THIS CASE, THE MIGRATED IMPLANT LED TO A REVISION AND THEREFORE FAILED TO PERFORM AS INTENDED. FOR THIS REASON AND OUT OF ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803 REQUIREMENTS, THIS EVENT WAS REPORTED. PLEASE NOTE THE EVENT CONCLUSION CODE (B)(4) IN THIS MDR REPORT IS REFERRING TO THE PATIENT, NOT THE SURGEON OR USER. NOT DEVICE DEFECT OR MALFUNCTION RELATED.

    Description of Event or Problem · 1

    A PATIENT RECEIVED CERVICAL FUSION BUT DID NOT FOLLOW THE SURGEON'S POST-OPERATION ADVICE TO WEAR A SOFT COLLAR TO HELP STABILIZE THE SPINE DURING FUSION AND WAS ACTIVE IN GAMING WITHIN 14 DAYS OF THE SURGERY. THIS PATIENT LATER EXPERIENCED PAIN ON HIS RIGHT ARM. THE SURGEON BELIEVED THE GAMING ACTIVITY COULD HAVE LED TO AN IMPLANT MIGRATION RESULTED IN THE OBSERVED PAIN. THE SURGEON DECIDED TO PERFORM A REVISION SURGERY TO REMOVE AND REPLACE THE IMPLANT. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS ALSO NO REPORTED DEVICE MALFUNCTION BEFORE OR AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826666 DTRAX CERVICAL CAGE-B INTERVERTEBRAL CERVICAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 981008 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention