BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVIX CERVICAL CAGE-B

    MDR report key: 8338075 · Received February 13, 2019

    Report

    Report Number
    3009394448-2019-00001
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    February 6, 2017
    Report Date
    February 12, 2019
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY
    Product Code
    ODP
    UDI-DI
    10852776006000
    PMA / PMN Number
    K122801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT DID NOT RESULT IN A DEATH OR LIFE-THREATENING INJURY. THERE WAS NO DEVICE MALFUNCTION REPORTED WITH THE DEVICES. PATIENT IS EX-FOOTBALL PLAYER, WITH HISTORY OF PREVIOUS INJURIES, INCLUDING BROKEN JAW AND LOWER BACK INJURY, RESULTING IN A FRACTURE AT L2. PATIENT REPORTED EXPERIENCING A "TRAUMATIC EVENT" APPROXIMATELY 6 MONTHS POST PROCEDURE, WHEN HE TURNED HIS NECK ABRUPTLY, HEARD A "CRACKING NOISE" AND EXPERIENCED MORE SEVERE PAIN. PHYSICIAN NOTED A BICYCLE ACCIDENT IN MEDICAL RECORDS FOR THE 2 MONTHS FOLLOW UP VISIT, PATIENT DENIES THIS OCCURRED. IN (B)(6) 2017, PATIENT SOUGHT 2ND OPINIONS FROM 3 ADDITIONAL PHYSICIANS, WHO ALL NOTED THAT THERE WERE FRACTURES AND THAT 3 OF 4 CAGES MIGRATED. PATIENT REPORTS THAT THESE 3 PHYSICIANS RECOMMENDED A REVISION PROCEDURE BUT DECLINED TO OPERATE. ORIGINAL SURGEON OFFERED A REVISION PROCEDURE, PATIENT DECLINED. THE EVENT IS BEING REPORTED BECAUSE TO DATE, THE PATIENT REPORTS SYMPTOMS REMAIN UNRESOLVED, AND ANOTHER SURGERY TO ADDRESS HIS SYMPTOMS WAS RECOMMENDED BY HIS SURGEON.

    Description of Event or Problem · 1

    ON (B)(6) 2019 PATIENT CONTACTED PMT AND REPORTED THAT ON (B)(6) 2017, HE UNDERWENT A POSTERIOR FUSION PROCEDURE AT C3-C4, AND C4-C5 LEVELS, WITH PMT CAGES. HE ALSO REPORTED A POSSIBLE TRAUMATIC INCIDENT POST PROCEDURE AS WELL AS FRACTURES AT C2, C5 AND C6, AS WELL AS AND 3 CAGE MIGRATIONS. CURRENTLY, ALMOST TWO YEARS POST PROCEDURE, PATIENT REPORTS PAIN, BOTH IN THE ARM AND NECK, INCONTINENCE, ARM NUMBNESS AND TINGLING, DIFFICULTY TO MOVE HIS RIGHT HAND AND TENDENCY TO LOSE CONSCIOUSNESS UPON ABRUPT NECK TURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129498 CAVIX CERVICAL CAGE-B INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP PROVIDENCE MEDICAL TECHNOLOGY PD-32-200 1005283 10852776006000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention