BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-B

    MDR report key: 10048252 · Received May 12, 2020

    Report

    Report Number
    3009394448-2020-00004
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    May 6, 2020
    Report Date
    May 11, 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

    A (B)(6)-YEAR-OLD MALE UNDERWENT POSTERIOR CERVICAL FUSION SURGERY ON (B)(6) 2020 WITH CERVICAL CAGES PLACED BILATERALLY POSTERIORLY AT C4-C5, C5-C6, C6-C7. PATIENT IS A SMOKER AND HAS HISTORY OF PREVIOUS CERVICAL SPINAL SURGERY; PROCEDURE WAS TO ADDRESS PSEUDARTHROSIS FROM PREVIOUS SURGERY. ALL SIX CERVICAL CAGES WERE IMPLANTED SUCCESSFULLY BUT A NOTE WAS MADE ABOUT DIFFICULTY TO ACCESS FACET JOINT DUE TO PATIENT ANATOMY AND PREVIOUS SURGERY. APPROXIMATELY 3 WEEKS LATER, PATIENT COMPLAINED OF RIGHT SIDE PAIN PROMPTING IMAGING TO BE TAKEN. IMAGING SUGGESTED CERVICAL CAGES PLACED ON THE RIGHT SIDE MAY BE MAL-POSITIONED, POTENTIALLY CAUSING PATIENT PAIN. A REVISION SURGERY WAS PERFORMED (B)(6) 2020 TO REMOVE ALL THREE CERVICAL CAGES PLACED ON THE RIGHT SIDE (C4-C7) AND REPLACE WITH LATERAL MASS INSTRUMENTATION. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. PATIENT IS RECOVERING AS EXPECTED.

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD MALE UNDERWENT POSTERIOR CERVICAL FUSION SURGERY ON (B)(6) 2020 WITH CERVICAL CAGES PLACED BILATERALLY POSTERIORLY AT C4-C5, C5-C6, C6-C7. PATIENT IS A SMOKER AND HAS HISTORY OF PREVIOUS CERVICAL SPINAL SURGERY; PROCEDURE WAS TO ADDRESS PSEUDARTHROSIS FROM PREVIOUS SURGERY. ALL SIX CERVICAL CAGES WERE IMPLANTED SUCCESSFULLY BUT A NOTE WAS MADE ABOUT DIFFICULTY TO ACCESS FACET JOINT DUE TO PATIENT ANATOMY AND PREVIOUS SURGERY. APPROXIMATELY 3 WEEKS LATER, PATIENT COMPLAINED OF RIGHT SIDE PAIN PROMPTING IMAGING TO BE TAKEN. IMAGING SUGGESTED CERVICAL CAGES PLACED ON THE RIGHT SIDE MAY BE MAL-POSITIONED, POTENTIALLY CAUSING PATIENT PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO REMOVE ALL THREE CERVICAL CAGES PLACED ON THE RIGHT SIDE (C4-C7) AND REPLACE WITH LATERAL MASS INSTRUMENTATION. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. PATIENT IS RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513005 CAVUX CERVICAL CAGE-B INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-31-200 048768 00852776006423

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention