BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 11662117 · Received April 13, 2021

    Report

    Report Number
    3004987282-2021-00015
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 27, 2021
    Manufacturer
    SPINAL KINETICS LLC
    Product Code
    MJO
    PMA / PMN Number
    P170036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A1: (B)(6), A2: 58 YEARS, ON (B)(6) 1962, B4: 27-JUL-2021, D9: YES, G3: 27-JUL-2021, G6: FOLLOW-UP #1, H2: CORRECTION, ADDITIONAL INFORMATION, DEVICE EVALUATION, H3: YES. H6: TYPE OF INVESTIGATION: 10, 3331. INVESTIGATION FINDINGS: 213. H10: IT WAS REPORTED THAT THE PATIENT HAD INCREASINGLY EXPERIENCED BILATERAL ARM PAIN. THE RADIOGRAPHIC IMAGES WERE REVIEWED WHERE DEGENERATIVE CHANGES, SEVERE HEIGHT LOSS AND OSTEOLYTIC CHANGES WERE OBSERVED. THE DISC REPLACEMENT SIZING APPEARED TO BE OVERSIZED. THE DEVICE WAS INTACT; HOWEVER, SUSTAINED DAMAGE AT THE TIME OF REMOVAL. NO TISSUE SAMPLES, ALTHOUGH INFLAMMATION WAS NOTED, WERE TAKEN FOR MICROBIOLOGICAL OR HISTOPATHOLOGY OR LABORATORY RESULTS PROVIDED. THE DEVICE HAD NOT EXPERIENCED MECHANICAL FAILURE. THE FAILURE OF THIS PROCEDURE WAS MOST LIKELY DUE TO THE INAPPROPRIATE SIZING, AS INDICATED IN THE RADIOGRAPHIC IMAGES PROVIDED AND AS DETERMINED BY THE ATTENDING SURGEON.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE. ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    M6-C DEVICE REMOVED DUE TO INCREASING BILATERAL ARM PAIN AND SUBSIDENCE. THE DEVICE WAS EXPLANTED. THE DEVICE WAS INTACT AT TIME OF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559330 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC 6MM LARGE LONG 10769

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention