BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT "M" STANDARD 19X19 H5 US

    MDR report key: 16657571 · Received March 31, 2023

    Report

    Report Number
    3004788213-2023-00024
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 6, 2023
    Report Date
    June 10, 2024
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018937
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED FOR USE IN OR MARKETED WITHIN THE US, HOWEVER IT IS A SIMILAR PRODUCT TO THOSE CLEARED BY P110009 UNDER PRODUCT CODE MJO. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D4: LOT NUMBER AND UDI NUMBER, D9, G1, AND H3. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED NO DAMAGE TO THE DEVICE, AND IT WAS RETURNED PROPERLY ASSEMBLED. DHR REVIEW THE DHR WAS REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE¿S CONTROL. POTENTIAL ROOT CAUSE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. DEVICE USAGE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFERIOR PLATE OF A MOBI-C IMPLANT DISASSEMBLED AFTER IT WAS INSTALLED INTRA-OPERATIVELY. THERE WAS A DELAY OF 4 MINUTES WHILE THE IMPLANT COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFERIOR PLATE OF A MOBI-C IMPLANT DISASSEMBLED AFTER IT WAS INSTALLED INTRA-OPERATIVELY. THERE WAS A DELAY OF 4 MINUTES WHILE THE IMPLANT COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397974 MOBI-C IMPLANT "M" STANDARD 19X19 H5 US MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L083277 03662663018937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose