BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C P&F IMPLANT 13X15 H5

    MDR report key: 22329495 · Received June 25, 2025

    Report

    Report Number
    3004788213-2025-00037
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    November 13, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018333
    PMA / PMN Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 D9 AND H3. ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE. THE DEVICE IS DISASSEMBLED. ROOT CAUSE: THIS EVENT COULD BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. 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 HIGHRIDGE MEDICAL¿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 INTRA-OPERATIVELY, A MOBI-C P&F IMPLANT MIGRATED AND DISASSEMBLED AFTER IMPLANTATION. ALL THREE PIECES OF THE IMPLANT WERE RETRIEVED AND REPLACED WITH ANOTHER OF THE SAME SIZE; THERE WAS NO PATIENT IMPACT. HOWEVER, THERE WAS A REPORTED DELAY TO THE SURGERY OF APPROXIMATELY 45 MINUTES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRA-OPERATIVELY, A MOBI-C P&F IMPLANT MIGRATED AND DISASSEMBLED AFTER IMPLANTATION. ALL THREE PIECES OF THE IMPLANT WERE RETRIEVED AND REPLACED WITH ANOTHER OF THE SAME SIZE; THERE WAS NO PATIENT IMPACT. HOWEVER, THERE WAS A REPORTED DELAY TO THE SURGERY OF APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068811 MOBI-C P&F IMPLANT 13X15 H5 PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA L083513 03662663018333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown