BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-SB

    MDR report key: 10469030 · Received August 28, 2020

    Report

    Report Number
    3009394448-2020-00007
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 27, 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 PATIENT UNDERWENT A 2-LEVEL CIRCUMFERENTIAL CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY BILATERALLY. THE SAME DAY, THE PATIENT COMPLAINED OF RIGHT-SIDED DELTOID WEAKNESS, INITIATING A CT SCAN. THE CAGE AT C4-C5 ON THE RIGHT WAS NOTED TO BE POTENTIALLY MALPOSITIONED, WHICH COULD HAVE CONTRIBUTED TO THE DELTOID WEAKNESS. THE SAME DAY (EVENING), THE PATIENT UNDERWENT A REVISION PROCEDURE TO THE OR TO REMOVE THE CERVICAL CAGE AT C4-C5 ON THE RIGHT DURING WHICH TIME THE SURGEON PERFORMED A FORAMINOTOMY AND PLACED LATERAL MASS SCREWS. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. THE PATIENT IS RECOVERING WITH NO CLINICAL SEQUELAE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A PATIENT UNDERWENT A 2-LEVEL CIRCUMFERENTIAL CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY BILATERALLY. THE SAME DAY, THE PATIENT COMPLAINED OF RIGHT-SIDED DELTOID WEAKNESS, INITIATING A CT SCAN. THE CAGE AT C4-C5 ON THE RIGHT WAS NOTED TO BE POTENTIALLY MALPOSITIONED, WHICH COULD HAVE CONTRIBUTED TO THE DELTOID WEAKNESS. THE SAME DAY (EVENING), THE PATIENT UNDERWENT A REVISION PROCEDURE TO THE OR TO REMOVE THE CERVICAL CAGE AT C4-C5 ON THE RIGHT DURING WHICH TIME THE SURGEON PERFORMED A FORAMINOTOMY AND PLACED LATERAL MASS SCREWS. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. THE PATIENT IS RECOVERING WITH NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931270 CAVUX CERVICAL CAGE-SB INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-202 049144 00852776006423

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention