BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 19113127 · Received April 15, 2024

    Report

    Report Number
    3004987282-2024-00010
    Event Type
    Injury
    Date Received
    April 15, 2024
    Report Date
    April 15, 2024
    Manufacturer
    SPINAL KINETICS
    Product Code
    MJO
    PMA / PMN Number
    P170036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INSPECTION OF THE RETRIEVED M6-C, IN CONJUNCTION WITH THE CLINICAL DATA AND IMAGES PROVIDED, THE DEVICE HAD NOT FAILED MECHANICALLY AT THE TIME OF REMOVAL; HOWEVER, SOME IN VIVO DAMAGE WAS EVIDENT. SPECIFICALLY, THE DEVICE HAD NOT COLLAPSED AND THE ENDPLATES WERE NOT IN CONTACT; HOWEVER, FRAYING WAS PRESENT ON THE VISIBLE PORTION OF THE FIBER CONSTRUCT, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED OSTEOLYTIC LESIONS. DESTRUCTIVE EXAMINATION OF THE INNER SURFACES OF THE DEVICE IS NEEDED TO EXAMINE THE INTEGRITY OF THE INNER PORTION OF THE FIBER CONSTRUCT AND THE CORE. MICROBIOLOGY RESULTS WERE NOT PROVIDED, THEREFORE IT IS UNCLEAR IF INFECTION WAS SUSPECTED OR CONFIRMED, WHICH MAY HAVE CONTRIBUTED TO THE OBSERVED OSTEOLYSIS. THEREFORE, WHILE THE DEVICE DID NOT APPEAR TO HAVE FAILED MECHANICALLY, IN VIVO DAMAGE TO THE FIBER CONSTRUCT AND AN OSTEOLYTIC REACTION TO WEAR DEBRIS WAS LIKELY. THE BUILD LHR WAS EXAMINED INCLUDING THE FINAL INSPECTION RECORDS AND THE IN-PROCESS MEASUREMENTS. THERE WERE NO RELEVANT NCMRS ASSOCIATED WITH THIS LOT. THE DEVICES MET THE M6-C PRODUCT SPECIFICATION INCLUDING THE AXIAL STIFFNESS AND FLEXURAL RESISTANCE SPECIFICATIONS. RMF 0003 REV 38 LINE 12.73.4. - RESORPTION OR OSTEOLYSIS, WITHOUT INFECTION/INFECTED ABSCESS/INFECTED CYST, LEADING TO SURGICAL INTERVENTION WITH EXPLANTATION. RMF 0003 REV 38 LINE 12.20. - MIGRATION/LOOSENING, ACUTE REQUIRING ADDITIONAL SURGERY, WITH EXPLANTATION, INVOLVING PATIENT WITH ONLY A SINGLE LEVEL M6-C.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. LIMITED INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION AND RETURN OF DEVICE HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C CDL-627 DEVICE REMOVED "OSTEOLYSIS AND MECHANICAL LOOSENING". DEVCIE WAS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C CDL-627 DEVICE REMOVED "OSTEOLYSIS AND MECHANICAL LOOSENING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125646 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS CDL-627

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other