BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL CERVICAL DISC

    MDR report key: 10212915 · Received June 30, 2020

    Report

    Report Number
    3004987282-2020-00023
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    March 17, 2020
    Report Date
    August 3, 2021
    Manufacturer
    SPINAL KINETICS LLC
    Product Code
    MJO
    PMA / PMN Number
    P170036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A1: 20-39-A B4: (B)(6) -2021 G1: MR. (B)(6) SPINAL KINETICS LLC (B)(6) G3: (B)(6) 2021 G6: FOLLOW-UP #1 H2: ADDITIONAL INFORMATION H6: MEDICAL DEVICE PROBLEM CODE: 2682 - PATIENT - DEVICE INCOMPATIBILITY INVESTIGATION CONCLUSIONS: 4315 - CAUSE NOT ESTABLISHED H10: THE RADIOGRAPHIC IMAGES SHOWED EVIDENCE THAT THE DISC LOST HEIGHT AND THAT ONE OF THE DEVICES SHOWED RADIOLUCENCY. DUE TO LACK OF PRE-OPERATIVE AND POST-OPERATIVE IMAGING, FURTHER INTERPRETATION WAS NOT READILY AVAILABLE. THE DEVICE WAS NOT RETURNED; THUS, DEVICE EXAMINATION COULD NOT BE PERFORMED. NO MICROBIOLOGY OR PATHOLOGY LABORATORY TESTING RESULTS WERE PROVIDED; HOWEVER, IT WAS NOTED THAT A POSTERIOR LATERAL MASS WAS IDENTIFIED. IN SUMMARY, ONE DEVICE WAS INTACT AND ONE DEVICE WAS NOTED TO BE COLLAPSED. BASED ON THE INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO ASCERTAIN THE RELATIONSHIP BETWEEN THESE FACTORS AND THE COLLAPSED DISC WHICH LED TO THE EXPLANTATION.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE HAS BEEN REQUESTED. THIS WAS A TWO-LEVEL IMPLANTATION. IN THE US, THE M6-C ARTIFICIAL CERVICAL DISC IS INDICATED FOR USE FOLLOWING A SINGLE LEVEL DISCECTOMY IN SKELETALLY MATURE PATIENTS WITH INTRACTABLE DEGENERATIVE CERVICAL RADICULOPATHY WITH OR WITHOUT SPINAL CORD COMPRESSION AT ONE LEVEL FROM C3 - C7. THE IFU STATES THAT THE SAFETY AND EFFECTIVENESS OF THE M6-C ARTIFICIAL CERVICAL DISC HAS NOT BEEN ESTABLISHED IN PATIENTS WITH MORE THAN ONE CERVICAL LEVEL REQUIRING SURGERY. THIS IS ONE (1) OF TWO (2) REPORTS SUBMITTED ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TWO-LEVEL PATIENT WAS REVISED. BOTH DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678801 ARTIFICIAL CERVICAL DISC ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention