BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M "STANDARD" 15X17 H4.5

    MDR report key: 9987386 · Received April 22, 2020

    Report

    Report Number
    3004788213-2020-00035
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    June 13, 2019
    Report Date
    April 22, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018579
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED IN THE US. IT IS SIMILAR TO PRODUCT CODE MJO CLEARED UNDER P110009. THE DEVICE WAS NOT RETURNED AND PICTURES WERE NOT PROVIDED. THEREFORE, THE CAUSE CANNOT BE DETERMINED. MANUFACTURING RECORDS INDICATE THE DEVICE WAS CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. LABELING WAS REVIEWED AND FOUND TO CONTAIN ADEQUATE INSTRUCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOBI-C WAS IMPLANTED UPSIDE DOWN. LATER THAT DAY, A REVISION SURGERY OCCURRED AND THE IMPLANT WAS REMOVED AND REPLACED WITH AN ALTERNATE. THERE WAS NO ADDITIONAL SURGICAL OR PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449073 MOBI-C IMPLANT M "STANDARD" 15X17 H4.5 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MEDICAL NA L082197 03662663018579

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R