BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVUX CERVICAL CAGE-B 4MM

    MDR report key: 6790399 · Received August 11, 2017

    Report

    Report Number
    3009394448-2017-00003
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    December 2, 2016
    Report Date
    July 25, 2017
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Product Code
    ODP
    UDI-DI
    00852776006003
    PMA / PMN Number
    K161642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DID NOT RESULT IN A DEATH OR A LIFE-THREATENING INJURY. THERE WAS NO DEVICE DEFECT OR MALFUNCTION REPORTED WITH THE DEVICES. THE PATIENT EXPERIENCED UNRELIEVED NUMBNESS AND WEAKNESS OF THE LEFT ARM SINCE THE INITIAL CAGE IMPLANTATION WHOSE CAUSE IS UNCERTAIN. WHEN A CT AND EMG SCAN WAS PERFORMED, THE SURGEON OBSERVED THE CAGES WERE PLACED TOO MEDIALLY. AS A RESULT, THE SURGEON PERFORMED A SURGICAL RE-INTERVENTION TO REMOVE ALL IMPLANTED CAGES FROM C4-C7 AND, IN ADDITION, PERFORMED A LAMINOTOMY AND FORAMINOTOMY. TO DATE, THE PATIENT'S SYMPTOMS STILL HAVE NOT BEEN RESOLVED. FOR THIS REASON, THIS EVENT WAS REPORTED. IT IS NOTED THAT THIS CASE USED THREE DIFFERENT CAGE IMPLANT LOTS DURING PROCEDURE ON THE SAME DAY FOR THE SAME PATIENT. THIS MDR IS FOR LOT 1005037. THE OTHER TWO LOTS FOR THIS EXACT SAME CASE WILL BE REPORTED ON SEPARATE MDRS.

    Description of Event or Problem · 1

    A PATIENT WHO RECEIVED POSTERIOR C4-C7 CERVICAL INTERVERTEBRAL FUSION ON (B)(6) 2016 HAD TO GO THROUGH A RE-INTERVENTION ON (B)(6) 2017 TO PREVENT THE POTENTIAL FOR PERMANENT IMPAIRMENT OF THE LEFT ARM. THE IMPLANTED CAGES WERE PLACED MEDIALLY ENOUGH TO RESULT IN THE PATIENT EXPERIENCING LEFT ARM NUMBNESS AND WEAKNESS FOR ABOUT 6 MONTHS BEFORE THE RE-INTERVENTION. ALL IMPLANTED CERVICAL CAGES FROM C4-C7 WERE REMOVED WITH LAMINOTOMY AND FORAMINOTOMY DURING PROCEDURE. BUT, THE PATIENT'S SYMPTOMS ARE STILL NOT TOTALLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569316 CAVUX CERVICAL CAGE-B 4MM CERVICAL INTERVERTEBRAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 1005037 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention