BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTRAX CERVICAL CAGE-B

    MDR report key: 6179699 · Received December 15, 2016

    Report

    Report Number
    3009394448-2016-00011
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 12, 2015
    Report Date
    November 12, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT A DEATH SITUATION. THERE WAS NO LIFE-THREATENING INJURY. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THIS CASE EITHER. IT WAS NOTED THAT THE PATIENT HAS PREVIOUS ACDF AND SEVERE KYPHOSIS IN THIS CASE. THIS PATIENT'S ANATOMY AND CONDITION MAY BE CONTRIBUTING TO THE NERVE PALSY AND WEAKNESS AS WELL AS THE FACET FRACTURE. ALTHOUGH THERE WAS NO NERVE IMPINGEMENT EVIDENT IN THE CT IMAGES THAT COULD BE CONTRIBUTING TO THE PATIENT'S POST-OPERATION SYMPTOMS AND LEADING TO A RE-INTERVENTION, THERE WAS FACET FRACTURE WITH UNKNOWN CAUSE REPORTED. FOR THIS REASON, PROVIDENCE DECIDED TO REPORT THIS EVENT OUT OF ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803 REQUIREMENTS. IT IS ALSO NOTED THAT THERE ARE TWO DIFFERENT LOTS INVOLVED IN THIS CASE. THIS MDR REPORTS ONE OF THE TWO LOTS (LOT 1096682) USED IN THIS CASE (USED ON THE SAME PATIENT, ON THE SAME DAY, AND BY THE SAME SURGEON). NOTE: THIS MDR IS A FOLLOW-UP (SUPPLEMENTAL) MDR TO CORRECT A POSSIBLE LOT NUMBER ERROR IN THE ORIGINAL SUBMISSION. THE ORIGINAL SUBMISSION POSSIBLY ENTERED LOT 1116223 INSTEAD OF 109668. NOT DEVICE DEFECT OR MALFUNCTION RELATED.

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT A DEATH SITUATION. THERE WAS NO LIFE-THREATENING INJURY. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THIS CASE EITHER. IT WAS NOTED THAT THE PATIENT HAS PREVIOUS ACDF AND SEVERE KYPHOSIS IN THIS CASE. THIS PATIENT'S ANATOMY AND CONDITION MAY BE CONTRIBUTING TO THE NERVE PALSY AND WEAKNESS AS WELL AS THE FACET FRACTURE. ALTHOUGH THERE WAS NO NERVE IMPINGEMENT EVIDENT IN THE CT IMAGES THAT COULD BE CONTRIBUTING TO THE PATIENT'S POST-OPERATION SYMPTOMS AND LEADING TO A RE-INTERVENTION, THERE WAS FACET FRACTURE WITH UNKNOWN CAUSE REPORTED. FOR THIS REASON, PROVIDENCE DECIDED TO REPORT THIS EVENT OUT OF ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803 REQUIREMENTS. IT IS ALSO NOTED THAT THERE ARE TWO DIFFERENT LOTS INVOLVED IN THIS CASE. THIS MDR REPORTS ONE OF THE TWO LOTS (LOT 1096682) USED IN THIS CASE (USED ON THE SAME PATIENT, ON THE SAME DAY, AND BY THE SAME SURGEON). NOT DEVICE DEFECT OR MALFUNCTION RELATED.

    Description of Event or Problem · 1

    PATIENT HAD SEVERE KYPHOSIS AND A C4-C7 ACDF IN (B)(6) 2015 PRIOR TO RECEIVING POSTERIOR CERVICAL FUSION. AFTER THE CERVICAL FUSION, THE PATIENT WOKE UP WITH NERVE PALSY AND WEAKNESS. THE PATIENT'S SYMPTOM WAS MONITORED BY THE SURGEON WHO HAD A CONCERN THAT THE COMBINATION OF NERVE PALSY AND WEAKNESS COULD BE DUE TO POSSIBLE PROXIMITY OF THE IMPLANT TO ARTERY NERVES AND FACET FRACTURE. THE SURGEON LATER CONFIRMED THAT THERE WAS NO INTERVENTION NECESSARY BECAUSE CT IMAGES SHOWED THE IMPLANT WAS NOT IMPINGING ON ANY NERVES. HOWEVER, THE CAUSE OF THE FACET FRACTURE WAS INCONCLUSIVE ACCORDING TO THE SURGEON. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS ALSO NO DEVICE DEFECT OR MALFUNCTION OF ANY TYPE REPORTED.

    Description of Event or Problem · 1

    PATIENT HAD SEVERE KYPHOSIS AND A C4-C7 ACDF IN (B)(6) 2015 PRIOR TO RECEIVING POSTERIOR CERVICAL FUSION. AFTER THE CERVICAL FUSION, THE PATIENT WOKE UP WITH NERVE PALSY AND WEAKNESS. THE PATIENT'S SYMPTOM WAS MONITORED BY THE SURGEON WHO HAD A CONCERN THAT THE COMBINATION OF NERVE PALSY AND WEAKNESS COULD BE DUE TO POSSIBLE PROXIMITY OF THE IMPLANT TO ARTERY NERVES AND FACET FRACTURE. THE SURGEON LATER CONFIRMED THAT THERE WAS NO INTERVENTION NECESSARY BECAUSE CT IMAGES SHOWED THE IMPLANT WAS NOT IMPINGING ON ANY NERVES. HOWEVER, THE CAUSE OF THE FACET FRACTURE WAS INCONCLUSIVE ACCORDING TO THE SURGEON. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS ALSO NO DEVICE DEFECT OR MALFUNCTION OF ANY TYPE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827557 DTRAX CERVICAL CAGE-B INTERVERTEBRAL CERVICAL FUSION DEVICE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 109668 00852776006003

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention