BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT; SIZE UNKNOWN

    MDR report key: 21830449 · Received April 11, 2025

    Report

    Report Number
    3004788213-2025-00014
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    June 7, 2023
    Report Date
    May 7, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEEH10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN B3, B5, AND D6A. 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 CAN BE ATTRIBUTED TO TEMPORARILY PLACING THE MOBI-C DEVICE TOO FAR POSTERIORLY IN THE JOINT. IT WAS REPORTED THAT THERE WAS SLIGHT RESISTANCE AT C6/7 DURING IMPLANT INSERTION AND THE DISTRACTOR WAS SPREAD TO HELP IMPLANT PLACEMENT. ACCORDING TO THE STG, THE TRIALS SHOULD BE USED TO IDENTIFY THE CORRECT HEIGHT. IF THE TRIAL IS DIFFICULT TO INSERT, A SMALLER MOBI-C SHOULD BE SELECTED. THE STG PROVIDES NO INSTRUCTION FOR THE USER TO DISTRACT FURTHER IF THE IMPLANT IS TOO TALL FOR THE DISC SPACE. THE DEVICE STG STATES DO NOT OVERSTUFF HEIGHT. THERE ARE ALSO INSTRUCTIONS IN THE DEVICE STG FOR CORRECT IMPLANT INSERTER DEPTH STOP USAGE. CORRECT DEPTH STOP USAGE PREVENTS THE IMPLANT FROM BEING PLACED TOO POSTERIORLY IN THE JOINT. DHR REVIEW: THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED, THEREFORE A DHR REVIEW IS UNABLE TO BE PERFORMED. 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 DURING A MOBI-C PLACEMENT, THE PROSTHESIS HAD GONE INTO THE LUMBAR CANAL AND THE PATIENT HAD REMAINED TETRAPLEGIC FOR A LONG TIME BUT HAD PARTIALLY RECOVERED. FURTHER INFORMATION REGARDING PATIENT IMPACT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C PROSTHESIS INSTALLED AT C6/7 WAS PLACED TOO DEEPLY AND HAD SUNK INTO THE CERVICAL CANAL INTRA-OPERATIVELY. THE DISC SPACE WAS PREPARED BY REMOVING THE DISC MATERIAL, CARTILAGE, AND PARTIAL CORTICAL BONE. THEN THE RETRACTOR WAS USED TO OBTAIN PARALLELISM. THE MOBI-C PROSTHESIS WAS IMPLANTED WITHOUT ISSUE AT C5/6. HOWEVER, THERE WAS SLIGHT RESISTANCE AT C6/7 AND THE LABORATORY REPRESENTATIVE WITH THE SURGEON ADVISED TO SPREAD THE DISTRACTOR TO HELP INTRODUCTION. SUBSEQUENT FLUOROSCOPY IDENTIFIED THE PLACEMENT WAS TOO DEEP AT WHICH TIME THE SURGEON REMOVED THE PROSTHESIS AND REINSERTED IT CORRECTLY. THE PATIENT HAD TETRAPLEGIA IMMEDIATELY POST-OPERATIVELY, BUT HAD PARTIALLY RECOVERED BY ABOUT 10 MONTHS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022457 MOBI-C IMPLANT; SIZE UNKNOWN PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability