BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 4201047 · Received October 27, 2014

    Report

    Report Number
    1030489-2014-04133
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 13, 2011
    Report Date
    March 6, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 C6-C7. AT 76 MONTHS POST-OP, THE PATIENT UNDERWENT ADDITIONAL SURGERY DUE TO ADJACENT LEVEL PROBLEM. THE ARTIFICIAL DISC WAS REMOVED AND FUSION PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682028 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA 115760

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention BONE SCREW, LOCKING SCREW