BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M6-C

    MDR report key: 8576258 · Received May 2, 2019

    Report

    Report Number
    3004987282-2019-00015
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 3, 2019
    Report Date
    December 5, 2020
    Manufacturer
    SPINAL KINETICS LLC
    Product Code
    MJO
    PMA / PMN Number
    P170036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: A2 AGE, A4 PATIENT WEIGHT, B6 RELEVANT TESTS/LABORATORY DATA, B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS.

    Additional Manufacturer Narrative · 0

    THE LIMITED RADIOGRAPHS PROVIDED WERE REVIEWED. IT WAS NOT POSSIBLE TO ASSESS THE POTENTIAL ROLE OF SURGICAL TECHNIQUE OR PATIENT SELECTION BASED ON THE PROVIDED INFORMATION. NO SERIAL OR LOT NUMBER HAS BEEN PROVIDED, THEREFORE, A REVIEW OF THE LOT HISTORY RECORDS FOR THIS DEVICE COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED; THUS, DEVICE EXAMINATION COULD NOT BE PERFORMED. HOWEVER, IT WAS NOTED THAT THE FIBERS WERE ONLY PARTIALLY PRESENT AND THAT THE CORE COULD NOT BE FOUND. WHILE THE DEVICE EXPERIENCED LOSS OF HEIGHT AND THERE APPEARED TO BE RESORPTION OR OSTEOLYSIS PRESENT, BASED ON THE LIMITED INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE EVENT.

    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 HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN M6-C ARTIFICIAL CERVICAL DISC IMPLANTED IN (B)(6) 2011 WAS REMOVED. THE PATIENT REPORTEDLY HAD OSTEOLYSIS. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367193 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention