BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOVI-C CERVICAL DISC PROSTHESIS

    MDR report key: 3938557 · Received June 13, 2014

    Report

    Report Number
    3004788213-2014-00011
    Event Type
    Injury
    Date Received
    June 13, 2014
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110002
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT OF IDE STUDY DEVELOPED SEVERE NECK AND ARM PAIN 7 YEARS AFTER IMPLANT. REPORT INDICATES SMALL ADJACENT HNP WITH INSTABILITY AND SOME EXPOSURE OF TDR SUPERIOR PLATE ANTERIORLY DUE TO BONE RESORPTION. SURGEON INDICATED TDR WAS NOT LOOSE BUT HE DECIDED TO REMOVE ALL VARIABLES TO ALLEVIATE PT'S PAIN. SURGEON COMMENTS INDICATE MUCH FIBROUS TISSUE IN DISC SPACE WITH NO DEVICE LOOSENING EVIDENT. TDR REMOVED AND REPLACED WITH ACDF CAGE AND PLATE.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348969 MOVI-C CERVICAL DISC PROSTHESIS MOBI-C CERVICAL DISC MJO LDR MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1