BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-X

    MDR report key: 10469090 · Received August 28, 2020

    Report

    Report Number
    3009394448-2020-00006
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    August 16, 2020
    Report Date
    August 20, 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 RECEIVED A SINGLE LEVEL POSTERIOR CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY AT C6-C7. THE PATIENT HAD A PREVIOUS 3-LEVEL ACDF AND A PREVIOUS C7-T1 POSTERIOR CERVICAL FUSION. NO ABNORMAL ANATOMY WAS NOTED IN THE INDEX PROCEDURE OTHER THAN THE PREVIOUS FUSION AT C7-T1 REQUIRING A NEED TO APPROACH THE TARGET LEVEL AT A SLIGHTLY HIGHER ANGLE RELATIVE TO THE FACET JOINT ANGLE. THE PATIENT RETURNED ONE DAY LATER COMPLAINING OF RIGHT ARM PAIN, INITIATING IMAGING. IN A POST-OPERATIVE CT, THE SURGEON SUSPECTED THE CERVICAL CAGES WERE MALPOSITIONED. THE CERVICAL CAGE ON THE RIGHT SIDE WAS REMOVED AND REPLACED WITH ANOTHER CERVICAL CAGE. THE CERVICAL CAGE ON THE LEFT SIDE WAS MALPOSITIONED AND REPOSITIONED. PATIENT IS RECOVERING WELL WITH NO ARM PAIN OR CLINICAL SEQUELAE. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 A PATIENT RECEIVED A SINGLE LEVEL POSTERIOR CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY AT C6-C7. THE PATIENT HAD A PREVIOUS 3-LEVEL ACDF AND A PREVIOUS C7-T1 POSTERIOR CERVICAL FUSION. THE PATIENT RETURNED ONE DAY LATER COMPLAINING OF RIGHT ARM PAIN, INITIATING IMAGING. IN A POST-OPERATIVE CT, THE SURGEON SUSPECTED THE CERVICAL CAGES WERE MALPOSITIONED. THE CERVICAL CAGE ON THE RIGHT SIDE WAS REMOVED AND REPLACED WITH ANOTHER PROVIDENCE MEDICAL TECHNOLOGY CERVICAL CAGE. ALSO, THE CERVICAL CAGE ON THE LEFT SIDE WAS ALSO MALPOSITIONED AND REPOSITIONED. PATIENT IS RECOVERING WELL WITH NO ARM PAIN. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932434 CAVUX CERVICAL CAGE-X INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-203 050138 00852776006423

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention