BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 2955749 · Received February 11, 2013

    Report

    Report Number
    1030489-2013-00449
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 18, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND OPTICAL EXAMINATION OF IMPLANT REVEALS LIGHT SURFACE SCRATCHES, CONSISTENT WITH EXPLANT. DIMENSIONAL EVALUATION OF SPHERICAL FEATURE HEIGHT (5MM +/-0.1), OVERALL HEIGHT (6MM +/-0.1), AND OVERALL WIDTH (17.8 +/-0.2) WERE ALL FOUND TO BE WITHIN SPRINT SPECIFICATION. WITNESS MARKS CONSISTENT WITH TYPICAL IMPLANT USAGE NOTED ON INTERFACING SURFACES OF INTERVERTEBRAL PORTIONS OF IMPLANT ASSEMBLY. NO MATERIAL OR FUNCTIONAL DEFECT IDENTIFIED WITH RESPECT TO THE IMPLANT. VISUAL AND OPTICAL EXAMINATION OF BONE SCREWS DID NOT IDENTIFY CRACK, FRACTURE, BREAKAGE, OR EXCESSIVE WEAR. DIMENSIONAL INSPECTION OF OVERALL LENGTH (OAL) AND MAJOR DIAMETER FOUND ALL BONE SCREWS TO BE WITHIN PRINT SPECIFICATION. UNABLE TO IDENTIFY MATERIAL OR FUNCTIONAL DEFECT WITH RESPECT TO THE IMPLANT. AFTER VISUAL, OPTICAL, AND DIMENSIONAL EVALUATION, THE IMPLANT APPEARS TO FUNCTION AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION OF THE DEVICE IS IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION TO REMOVE THE ARTIFICIAL CERVICAL DISC AT C5-C6 AND REPLACE WITH AN ANTERIOR CERVICAL PLATE AND INTERBODY DEVICE AT THE EXPLANTED LEVEL AND ADJACENT LEVEL. REASON FOR THE SURGERY WAS THE PATIENT STILL HAD NECK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59038 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA W08B2382

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention