BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 8672980 · Received June 5, 2019

    Report

    Report Number
    3004987282-2019-00021
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B3: 06-MAY-2019. D4: SERIAL #: (B)(6). MANUFACTURER NARRATIVE: B4: 11-MAY-2021. D8: NO. G1: MR. (B)(6). G2: DISTRIBUTOR/IMPORTER. G3: 11-MAY-2021. G6: FOLLOW-UP # 1. H2: CORRECTION, ADDITIONAL INFORMATION, DEVICE EVALUATION. H3: YES. H6: HEALTH EFFECT - IMPACT CODE: 4627. TYPE OF INVESTIGATION: 10, 3331. INVESTIGATION FINDINGS: 213. INVESTIGATION CONCLUSIONS: 4315. H10: A REVISION WAS PERFORMED. THE CLINICAL REASON FOR THE REVISION WAS NOT STATED. LIMITED INFORMATION WAS PROVIDED; NOTABLY, NO PRE-OPERATIVE, POST-OPERATIVE, INTERIM, OR FLEXION/EXTENSION RADIOGRAPHS. IT WAS NOT POSSIBLE TO ASSESS THE POTENTIAL ROLE OF SURGICAL TECHNIQUE OR PATIENT SELECTION BASED ON THE PROVIDED INFORMATION. THE IMPLANT WAS INTACT AS-RECEIVED. THE ENDPLATES WERE ATTACHED AND THE SHEATH WAS PRESENT. NO MICROBIOLOGY OR PATHOLOGY REPORTS WERE PROVIDED. THE CAUSE OF THIS EVENT WAS UNCLEAR. THE DEVICE DID NOT APPEAR TO HAVE FAILED MECHANICALLY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCE'S. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN M6-C ARTIFICIAL CERVICAL DISC WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464704 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC 6MM LARGE 4029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention