BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C P&F IMPLANT 15X17 H5

    MDR report key: 10714477 · Received October 21, 2020

    Report

    Report Number
    3004788213-2020-00193
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 27, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI#: (B)(4). THE COMPLAINT WAS CONFIRMED WITH PRODUCT RECEIVED FOR FAILURE OF MISPLACEMENT/DISASSEMBLY UPON PEEK JAW REMOVAL. VISUAL INSPECTION REVEALS NO DEFORMITIES. FUNCTIONAL TESTING CONFIRMED THAT THE PRODUCT COULD BE REASSEMBLED AND DISASSEMBLED WITHOUT DIFFICULTY. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IS SIMILAR TO THOSE CLEARED UNDER P110009. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE DEVICE EVALUATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOBIC-C IMPLANT DISASSEMBLED IN-SITU AFTER BEING IMPLANTED AND POSITIONED CORRECTLY; AFTER POSITIONING, THE SURGEON OPENED THE RETRACTOR WHICH CAUSED THE COMPONENTS TO SHIFT AND DISASSEMBLE IN THE DISC SPACE. THE IMPLANT WAS REMOVED AND REPLACED WITH AN ALTERNATIVE IMPLANT TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179513 MOBI-C P&F IMPLANT 15X17 H5 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L081709C129

    Patients

    Seq Age Sex Outcome Treatment
    1