BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 8962593 · Received September 4, 2019

    Report

    Report Number
    3004987282-2019-00035
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 6, 2019
    Report Date
    May 11, 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

    B4: 11-MAY-2021. D8: NO. G1: MR. (B)(6). G3: 11-MAY-2021. G6: FOLLOW-UP # 1. H2: ADDITIONAL INFORMATION, DEVICE EVALUATION. H3: YES. H6: HEALTH EFFECT - IMPACT: 4627. MEDICAL DEVICE PROBLEM CODE: 2682. TYPE OF INVESTIGATION: 10, 3331. INVESTIGATION FINDINGS: 140. INVESTIGATION CONCLUSIONS: 4315. THE CAUSE OF THIS EVENT WAS UNCLEAR. THE CORE AND FIBER CONSTRUCT EXPERIENCED MECHANICAL DAMAGE. THE DEVICE REMAINED FIXED; HOWEVER, DUE TO THE RADIOGRAPHIC DIAGNOSIS OF OSTEOLYSIS AND SUSPECTED INFECTION, THE DEVICE WAS REMOVED. NO MICROBIOLOGICAL CULTURE AND HISTOPATHOLOGY REPORTS OR FINDINGS WERE PROVIDED. IT IS NOT CLEAR IF THE SUSPECTED INFECTION WAS CONFIRMED AND MAY HAVE CONTRIBUTED TO THE REMOVAL OF THIS DEVICE.

    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 AN M6-C WAS REVISED. SURGEON OBSERVED PUS DURING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755803 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC 7MM LARGE LONG H80008211

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention