BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 9516930 · Received December 24, 2019

    Report

    Report Number
    3004987282-2019-00054
    Event Type
    Injury
    Date Received
    December 24, 2019
    Date of Event
    November 26, 2019
    Report Date
    May 19, 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

    A4: 79 KILOGRAMS. B3: 26-NOV-2019. B4: 19-MAY-2021. D8: NO. G1: MR. (B)(6). G3: 19-MAY-2021. G6: FOLLOW-UP # 1. H2: CORRECTION, ADDITIONAL INFORMATION, DEVICE EVALUATION. H3: YES. H6: HEALTH EFFECT - IMPACT: 4627. MEDICAL DEVICE PROBLEM CODE: 2682 . TYPE OF INVESTIGATION: 10, 3331. INVESTIGATION FINDINGS: 213. INVESTIGATION CONCLUSIONS: 4315. H10: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH EARLY SIGNS OF OSTEOLYSIS. THE RADIOGRAPHIC IMAGES WERE REVIEWED AND DEGENERATIVE CHANGES AND MINOR OSTEOLYSIS WERE OBSERVED. THE DEVICE WAS RECEIVED INTACT. SAMPLES WERE TAKEN FOR MICROBIOLOGICAL CULTURE AND HISTOPATHOLOGY, BUT NO LABORATORY REPORTS OR RESULTS WERE PROVIDED. THE DEVICE HAD NOT EXPERIENCED MECHANICAL FAILURE. THE FAILURE OF THIS PROCEDURE WAS LIKELY DUE TO DEGENERATIVE CHANGES AT THE ADJACENT LEVELS, AS THE DEVICE DID NOT APPEAR TO HAVE FAILED AT THE TIME OF REMOVAL.

    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 HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN M6-C ARTIFICIAL CERVICAL DISC WAS REMOVED DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309184 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC 6MM LARGE H80008439

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention