BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT; SIZE UNKNOWN

    MDR report key: 24152767 · Received January 22, 2026

    Report

    Report Number
    3004788213-2026-00010
    Event Type
    Injury
    Date Received
    January 22, 2026
    Report Date
    May 7, 2026
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEEH10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL METHOD CODE: 4109. ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. THE DEVICE WAS NOT RETURNED, SO EVALUATION IS BASED UPON THE IMAGES AND STUDY FINDINGS FROM THE REFERENCED MEDICAL JOURNAL ARTICLE. THE COMPLAINT IS UNREFUTED FOR MOBI-C IMPLANT FOR THE FAILURE OF SUBSIDENCE AND INFECTION RESULTING IN A REVISION SURGERY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    D4: THE UDI NUMBER IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS ARE NOT AVAILABLE. G4: 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. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. REFERENCE ARTICLE: KIM, K.R., CHIN, D.K., KIM, K.S., CHO, Y.E., SHIN, D.A., KIM, K.N., & KUH, S.U. (2021). REVISION SURGERY FOR A FAILED ARTIFICIAL DISC. YONSEI MEDICAL JOURNAL 62(3). HTTPS://DOI.ORG/10.3349/YMJ.2021.62.3.240.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION AND SUBSIDED MOBI-C IMPLANT AT C5-6 APPROXIMATELY 9 YEARS POST-OPERATIVELY. A REVISION WAS PERFORMED TO REMOVE THE IMPLANT AND REPLACE IT WITH AN ACDF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION AND SUBSIDED MOBI-C IMPLANT AT C5-6 APPROXIMATELY 9 YEARS POST-OPERATIVELY. A REVISION WAS PERFORMED TO REMOVE THE IMPLANT AND REPLACE IT WITH AN ACDF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376392 MOBI-C IMPLANT; SIZE UNKNOWN PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1