BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C P&F IMPLANT 19X19 H05

    MDR report key: 9666918 · Received February 4, 2020

    Report

    Report Number
    3004788213-2020-00014
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    June 1, 2017
    Report Date
    February 4, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME IS SIMILAR TO MOBI-C CERVICAL DISC PROSTHESIS. PMA NUMBER IS SIMILAR TO P110009. THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IS SIMILAR TO MB3995. THE DEVICE WAS NOT RETURNED, BUT PHOTOS OF X-RAYS WERE PROVIDED AND USED FOR ANALYSIS PURPOSES. THE CAUSE IS LIKELY ATTRIBUTED TO A USE ERROR ASSOCIATED WITH THE IMPROPER SELECTION OF IMPLANT SIZE AND/OR PATIENT DUE TO THE PATIENT HAVING A PREVIOUS FUSION ABOVE THIS LEVEL. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A DISC REPLACEMENT DEVICE THAT MIGRATED SIX WEEKS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131663 MOBI-C P&F IMPLANT 19X19 H05 SEE H10 MJO LDR MEDICAL NA 080888

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R