BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C P&F IMPLANT 17X19 H5

    MDR report key: 9845910 · Received March 17, 2020

    Report

    Report Number
    3004788213-2020-00036
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    January 22, 2019
    Report Date
    March 17, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018838
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED FOR USE WITHIN THE US; HOWEVER IT IS SIMILAR TO A DEVICE THAT IS CLEARED FOR USE WITHIN THE US. COMMON DEVICE NAME: THIS IS SIMILAR TO MOBI-C CERVICAL DISC PROSTHESIS. PMA/510(K) NUMBER: THIS IS SIMILAR TO P110009. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER. HOWEVER, A FULL EVALUATION WAS UNABLE TO BE PERFORMED SINCE THE NECESSARY DECONTAMINATION RECORDS WERE NOT PROVIDED. THE PROVIDED X-RAY SHOWS THE INFERIOR PLATE HAS MIGRATED, AND THE CORE HAS ALSO LIKELY MIGRATED. A VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY OBVIOUS INDICATIONS OF DAMAGE OR MALFUNCTION. THE CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. A REVIEW IF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE'S LABELING PROVIDES INSTRUCTIONS ON PROPER SITE PREPARATION AND DEVICE INSTALLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C DEVICE AT C5/6 THAT HAD BEEN IMPLANTED FOR ABOUT 2 MONTHS BECAUSE OF DEVICE MIGRATION THAT WAS CAUSING LEFT ARM PAIN AND WEAKNESS. A COMPETITOR'S PRODUCT WAS INSTALLED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308851 MOBI-C P&F IMPLANT 17X19 H5 SEE H10 MJO LDR MÉDICAL NA L082056 03662663018838

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R