BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 2522984 · Received April 9, 2012

    Report

    Report Number
    1030489-2012-00466
    Event Type
    Injury
    Date Received
    April 9, 2012
    Date of Event
    September 28, 2009
    Report Date
    March 13, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED DURING THE (B)(4) STUDY. THE APPROVED DEVICE IS PRODUCT CODE MJO, PMA NUMBER P060018. (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS FOLLOWING SURGERY FOR CERVICAL DISCECTOMY AND IMPLANT OF ARTIFICIAL CERVICAL DISC AT C4-C5, A CT MYELOGRAM CONFIRMED THAT THE C4-C5 LEVEL WHERE PRIOR ARTHROPLASTY WAS COMPLETED WAS FUSED. NO TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM MJO WARSAW ORTHOPEDICS NA 153650

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other