BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN MOTION COATED ENDPLATE, SMALL, 7.5 DEGREE LUMBAR, ARTIFICIAL DISC

    MDR report key: 1641249 · Received March 4, 2010

    Report

    Report Number
    1526439-2010-00044
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    January 13, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTING INSTRUMENTS (6 COMPONENTS) WERE RETURNED FOR EVALUATION. NO PROBLEM WAS FOUND DURING SIMULATED USE TESTING. THE PROCESS OF IMPLANTATION IS TECHNIQUE SENSITIVE AND NO CONNECTION COULD BE MADE BETWEEN THE EVENT AND ANY SHORTCOMING OF THE DEPUY SPINE PRODUCTS. IMPLANT REMAINS IN THE PATIENT AND NO ADVERSE OUTCOME HAS BEEN REPORTED TO DATE. IT IS POSSIBLE THAT LESS THAN OPTIMAL PLACEMENT OF THE IMPLANT COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION IN THE FUTURE.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT PLACEMENT OF THE IMPLANT WAS DIFFICULT WITH THE INSERTION INSTRUMENTS RESULTING IN A DELAY (90-MIN) TO THE CASE. AS A RESULT OF THIS PROBLEM, THE SURGEON REPORTED THAT THE PLACEMENT OF THE IMPLANT IS NOT CONSIDERED TO BE OPTIMAL. PRODUCT REMAINS IMPLANTED AND NO ADVERSE PATIENT OUTCOME HAS BEEN REPORTED TO DATE AS A RESULT OF THIS STIMULATION. AS THE EVENT RESULTED IN A SIGNIFICANT DELAY AND LESS THAN OPTIMAL PLACEMENT OF THE IMPLANT, AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN MOTION COATED ENDPLATE, SMALL, 7.5 DEGREE LUMBAR, ARTIFICIAL DISC ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR CORE: (B) (4), LOT UNK| ENDPLATE: (B) (4), LOT UNK