BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X17 H5

    MDR report key: 21866094 · Received April 18, 2025

    Report

    Report Number
    3004788213-2025-00016
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 26, 2025
    Report Date
    June 26, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018588
    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

    ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO IMPROPER ASSEMBLY OF THE IMPLANT ON THE INSERTER. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C P&F IMPLANT DISASSEMBLED DURING REPOSITIONING. THIS RESULTED IN A 30 MINUTE DELAY DUE TO REMOVAL OF THE CERVICAL PROSTHESIS, RECOVERY OF ALL PROSTHESIS PARTS, AND LOADING AND FITTING OF ANOTHER PROSTHESIS. THERE WAS NO REPORTED PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C P&F IMPLANT DISASSEMBLED DURING REPOSITIONING. THIS RESULTED IN A 30 MINUTE DELAY DUE TO REMOVAL OF THE CERVICAL PROSTHESIS, RECOVERY OF ALL PROSTHESIS PARTS, AND LOADING AND FITTING OF ANOTHER PROSTHESIS. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747824 MOBI-C IMPLANT M"STANDARD" 15X17 H5 PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA L083465 03662663018588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown