BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X17 H5

    MDR report key: 23977139 · Received January 6, 2026

    Report

    Report Number
    3004788213-2026-00001
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    November 26, 2025
    Report Date
    May 7, 2026
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018586
    PMA / PMN Number
    SEEH10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED, THEREFORE A DHR REVIEW IS UNABLE TO BE PERFORMED. THE DEVICE WAS NOT RETURNED BUT PHOTOS PROVIDED SHOW A FRAGMENT OF MOBI-C POLY-CORE. THE COMPLAINT IS CONFIRMED FOR MOBI-C IMPLANT FOR THE FAILURE OF FRACTURE. 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 REMAINDER OF THE UDI NUMBER IS UNKNOWN BECAUSE THE LOT NUMBER IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C PATIENT PRESENTED WITH LEG NUMBNESS TWO YEARS POST-OPERATIVELY. IMAGING REVEALED THAT THE C4-5 MOBI-C POLY-CORE WAS FRACTURED AT THE RIGHT ANTERIOR CORNER. A REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED IMPLANT AND REPLACE WITH AN ACDF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C PATIENT PRESENTED WITH LEG NUMBNESS TWO YEARS POST-OPERATIVELY. IMAGING REVEALED THAT THE C4-5 MOBI-C POLY-CORE WAS FRACTURED AT THE RIGHT ANTERIOR CORNER. A REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED IMPLANT AND REPLACE WITH AN ACDF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473527 MOBI-C IMPLANT M"STANDARD" 15X17 H5 PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA NI 03662663018586

    Patients

    Seq Age Sex Outcome Treatment
    1