BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 17X17 H5 OR 15X17 H5

    MDR report key: 23304113 · Received October 15, 2025

    Report

    Report Number
    3004788213-2025-00056
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Report Date
    December 30, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: EXPIRATION DATE: 9/01/2029 OR 5/01/2030. D4: UDI NUMBER: (B)(4) OR (B)(4). 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 H4: (B)(6) 2024 OR (B)(6) 2025. 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

    H6: ADDITIONAL METHOD CODE: 4110. ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED, HOWEVER THE IMAGING PROVIDED SHOWS THAT THE MOBI-C PROSTHESIS AT C4/5 HAS FISH MOUTHED AND THE PLATES ARE MISALIGNED. ADDITIONALLY, THE IMAGING SHOWS INADEQUATE POSTERIOR DISC PREP AND POTENTIALLY UNDER SIZING OF THE IMPLANT. IT IS BELIEVED THAT THE PE INSERT IS STILL CAPTURED WITHIN THE LATERAL STOPS OF THE INFERIOR PLATE. ROOT CAUSE: THIS EVENT COULD BE ATTRIBUTED TO INADEQUATE DISC PREP AND UNDER SIZING OF THE IMPLANT. DHR REVIEW: THE DHR WAS REVIEWED FOR BOTH LN L084000 AND LN L084361. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT HIGHRIDGE¿S CONTROL. DEVICE USAGE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SIX WEEK POST-OP X-RAY SHOWS A MISALIGNED MOBI-C IMPLANT. THE SURGEON BELIEVES THAT THE POLY CORE IS POTENTIALLY MIGRATED. THE PATIENT IS OKAY HOWEVER COMPLAINS OF DYSPHAGIA. A REVISION SURGERY IS NOT PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SIX WEEK POST-OPERATION X-RAY SHOWS A MISALIGNED MOBI-C IMPLANT. THE SURGEON BELIEVES THAT THE POLY CORE IS POTENTIALLY MIGRATED. THE PATIENT IS OKAY HOWEVER COMPLAINS OF DYSPHAGIA. A REVISION SURGERY IS NOT PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288477 MOBI-C IMPLANT M"STANDARD" 17X17 H5 OR 15X17 H5 PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA L084000 OR L084361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown