BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 1604469 · Received February 5, 2010

    Report

    Report Number
    1030489-2010-00137
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 7, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): PRESTIGE CERVICAL DISC 6MM X 14MM, CATALOG NUMBER 6961460, LOT NUMBER W08D0365, MANUFACTURE DATE 04/02/2008, EXPIRATION DATE 04/14/2013. PRESTIGE CERVICAL DISC 7MM X 14MM, CATALOG NUMBER 6961470, LOT NUMBER W07G2612, MANUFACTURE DATE 07/28/2007, EXPIRATION DATE 08/10/2012. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE DEVICES DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. TWO DISCS WERE RETURNED BY THE CUSTOMER. BOTH PACKAGED HAD BEEN OPENED BY THE CUSTOMER. THE 6MM X 14MM DEVICE HAD A 7X14 SUPERIOR COMPONENT IN THE PACKAGING, AND THE 7MM X 14MM DEVICE HAD A 6X14 SUPERIOR COMPONENT IN THE PACKAGING. AS THE SUPERIOR PORTION OF THESE IMPLANTS ARE NOT ETCHED WITH THE PART AND LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE IF THE SUPERIOR PORTIONS OF THESE IMPLANTS WERE SWAPPED DURING SURGERY. ALL DIMENSIONS OF RETURNED COMPONENTS ARE WITHIN SPECIFICATION. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTS DID NOT MATCH WHAT WAS TRIALED FOR. ALTHOUGH THE IMPLANT WAS USED IN SURGERY, NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM CERVICAL DISC MJO WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK