BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD" UNKNOWN SIZE

    MDR report key: 13003421 · Received December 14, 2021

    Report

    Report Number
    3004788213-2021-00164
    Event Type
    Injury
    Date Received
    December 14, 2021
    Report Date
    January 21, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION - THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. DHR REVIEW - THE LOT NUMBER WAS NOT PROVIDED, SO THE DHR WAS UNABLE TO BE REVIEWED. POTENTIAL ROOT CAUSE - A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO IMPLANTATION AT THE C7-T1 VERTEBRAL JUNCTION INDICATING AN OFF-LABEL USE. 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

    THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IS SIMILAR TO MB3XXX, WHICH IS CLEARED UNDER P110009, 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 REVISION WAS PERFORMED TO REMOVE A MOBI-C DEVICE THAT MIGRATED. THE PATIENT FELT SEVERE PAIN, LOWER LEG PARALYSIS, AND DECREASED ANAL TONE APPROXIMATELY TWO YEARS AFTER THE DEVICE WAS IMPLANTED AT C7-T1. A CORPECTOMY OF T1 WAS PERFORMED DURING THE REVISION WITH THE DEVICE REMOVAL. THE PATIENT RETURNED TO HIS DAILY LIFE, RETURNED TO WORK, AND IS UNDERGOING OUTPATIENT TREATMENT FOR SPASTICITY, HYPESTHESIA AND BLADDER DYSFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REMOVE A MOBI-C DEVICE THAT MIGRATED. THE PATIENT FELT SEVERE PAIN, LOWER LEG PARALYSIS, AND DECREASED ANAL TONE APPROXIMATELY TWO YEARS AFTER THE DEVICE WAS IMPLANTED AT C7-T1. A CORPECTOMY OF T1 WAS PERFORMED DURING THE REVISION WITH THE DEVICE REMOVAL. THE PATIENT RETURNED TO HIS DAILY LIFE, RETURNED TO WORK, AND IS UNDERGOING OUTPATIENT TREATMENT FOR SPASTICITY, HYPESTHESIA AND BLADDER DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900784 MOBI-C IMPLANT M"STANDARD" UNKNOWN SIZE MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention| H| S