BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE

    MDR report key: 13607101 · Received February 25, 2022

    Report

    Report Number
    3004788213-2022-00012
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    October 1, 2021
    Report Date
    March 24, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IS SIMILAR TO CATALOG NUMBER MB3XXX, WHICH IS CLEARED UNDER P110009 WITH PROCODE 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

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED, PHOTOS WERE NOT PROVIDED, AND X-RAYS WERE NOT PROVIDED, SO DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN TRAUMATIC, OPERATIONAL OR PATIENT FACTORS. DHR REVIEW: DHR REVIEW UNABLE TO BE COMPLETED AS PART INFORMATION IS NOT KNOWN. DEVICE USE: 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 MOBI-C DEVICE HAD EARLY WEAR OF THE POLYETHYLENE CORE LEADING TO MIGRATION AND DISLOCATION OF THE PROSTHESIS POST-OPERATIVELY. A REVISION SURGERY WITH ARTHRODESIS WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C DEVICE HAD EARLY WEAR OF THE POLYETHYLENE CORE LEADING TO MIGRATION AND DISLOCATION OF THE PROSTHESIS POST-OPERATIVELY. A REVISION SURGERY WITH ARTHRODESIS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334892 MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H