BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 4200737 · Received October 24, 2014

    Report

    Report Number
    1030489-2014-04131
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    January 3, 2006
    Report Date
    June 3, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR IMPLANT OF ARTIFICIAL CERVICAL DISC AT C4-C5 AT 24 MONTHS POST-OP, PATIENT HAS CALCIFICATION ANTERIOR TO THE IMPLANT. NO ADDITIONAL TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679693 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. NA 721060

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other BONE SCREW, LOCKING SCREW