BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M "STANDARD" 15X19 H4.5

    MDR report key: 16397120 · Received February 17, 2023

    Report

    Report Number
    3004788213-2023-00008
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 20, 2023
    Report Date
    June 10, 2024
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018623
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION. THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    PMA/510K: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C CERVICAL DISC DISASSEMBLED WHEN THE SURGEON ATTEMPTED TO REPOSITION THE DEVICE. IT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C DEVICE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C CERVICAL DISC DISASSEMBLED WHEN THE SURGEON ATTEMPTED TO REPOSITION THE DEVICE. IT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C DEVICE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110325 MOBI-C IMPLANT M "STANDARD" 15X19 H4.5 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L083116 03662663018623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose