BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-B

    MDR report key: 10388802 · Received August 10, 2020

    Report

    Report Number
    3009394448-2020-00005
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 4, 2020
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Product Code
    ODP
    UDI-DI
    00852776006423
    PMA / PMN Number
    K122801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, A MALE PATIENT UNDERWENT A CIRCUMFERENTIAL CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY, UNILATERALLY, ON THE LEFT AT C4-C5 AND C5-C6. THREE AND A HALF MONTHS LATER ON (B)(6) 2020, THE PATIENT RETURNED COMPLAINING OF PAIN. IMAGING CONFIRMED CAGES WERE PROUD POSTERIORLY WHICH POTENTIALLY CONTRIBUTED TO THE POST-OPERATIVE PAIN. BOTH CERVICAL CAGES PLACED POSTERIORLY WERE REMOVED ON (B)(6) 2020. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. PATIENT IS RECOVERING WELL WITH IMPROVED SYMPTOMS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A MALE PATIENT UNDERWENT A CIRCUMFERENTIAL CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY, UNILATERALLY, ON THE LEFT AT C4-C5 AND C5-C6. THREE AND A HALF MONTHS LATER ON (B)(6) 2020, THE PATIENT RETURNED COMPLAINING OF PAIN. IMAGING CONFIRMED CAGES WERE PROUD POSTERIORLY WHICH POTENTIALLY CONTRIBUTED TO THE POST-OPERATIVE PAIN. BOTH CERVICAL CAGES PLACED POSTERIORLY WERE REMOVED ON (B)(6) 2020. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. PATIENT IS RECOVERING WELL WITH IMPROVED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853057 CAVUX CERVICAL CAGE-B INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 048777 00852776006423

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention