BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHRTE ENDPLT OBLQ 10 DEG, 4

    MDR report key: 8734543 · Received June 26, 2019

    Report

    Report Number
    1526439-2019-51804
    Event Type
    Injury
    Date Received
    June 26, 2019
    Report Date
    June 11, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    MJO
    UDI-DI
    10705034015194
    PMA / PMN Number
    P040006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT IS IN PAIN ALL THE TIME WHEN THE PATIENT HAD UNDERGONE REVISION SURGERY A YEAR AND A HALF AGO AFTER THE JOHNSON AND JOHNSON CHARITÉ DISC HAS BEEN IMPLANTED IN 2006. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527506 CHRTE ENDPLT OBLQ 10 DEG, 4 PROSTHESIS, INTERVERTEBRAL DISC CHARITE MJO DEPUY SPINE INC WL049E029 10705034015194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention