BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTUS

    MDR report key: 20036256 · Received August 21, 2024

    Report

    Report Number
    MW5158688
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 13, 2024
    Manufacturer
    3SPINE INC.
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD DEVICE PLACED AT AN OUTSIDE FACILITY. PATIENT HAD PREVIOUS SURGERIES IN OUR HOSPITAL AND FOLLOWING UP. PATIENT ENDORSES PERSISTENT BACK PAIN RADIATING TO HER LEFT GROIN AD WELL AS BILATERAL SCIATICA. SHE WAS CONSIDERING SURGICAL INTERVENTION TO FIX HER DISC REPLACEMENT WHICH SHE'S CONCERNING MAY HAVE SLIPPED CAUSING SPINAL STENOSIS OR NERVE ROOT COMPRESSION. SHE NOW PRESENTS WITH PROGRESSIVE CALF PAIN AND NUMBNESS, AS WELL AS BILATERAL BACK AND HIP PAIN. LATERAL SUBSIDENCE OF THE SUPERIOR PLATES TOWARDS THE LEFT OF THE DEVICE BILATERALLY. POSTERIOR DISPLACEMENT OF THE RIGHT SUPERIOR PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363727 MOTUS PROSTHESIS, INTERVERTEBRAL DISC MJO 3SPINE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Disability