BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD" 17X19 H6

    MDR report key: 13929554 · Received March 28, 2022

    Report

    Report Number
    3004788213-2022-00021
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    February 28, 2022
    Report Date
    August 31, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED WITHIN THE US BUT IS SIMILAR TO MB3796, WHICH IS CLEARED UNDER P110009. 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

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR OF THE IMPLANT OVER TIME OR EXCESSIVE/OFF-AXIS FORCES EXPERIENCED AFTER IMPLANTATION. 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 ZIMVIE¿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 A MOBI-C DEVICE WAS REMOVED DUE TO POST-OPERATIVE NECK PAIN. THE PATIENT INITIALLY DID VERY WELL BUT BEGAN EXPERIENCING NECK PAIN WITHOUT RADICULOPATHY. THE MOBI-C WAS REMOVED AND REPLACED BY A CPESP DEVICE. THE PATIENT IS DOING WELL AFTER REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C DEVICE WAS REMOVED DUE TO POST-OPERATIVE NECK PAIN. THE PATIENT INITIALLY DID VERY WELL BUT BEGAN EXPERIENCING NECK PAIN WITHOUT RADICULOPATHY. THE MOBI-C WAS REMOVED AND REPLACED BY A CPESP DEVICE. THE PATIENT IS DOING WELL AFTER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878752 MOBI-C IMPLANT M"STANDARD" 17X19 H6 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L081129

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Hospitalization| R