BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEBRAL BODY TETHERING SYSTEM THE TETHER

    MDR report key: 20557600 · Received October 28, 2024

    Report

    Report Number
    MW5161727
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ZIMVIE / HIGHRIDGE MEDICAL LLC.
    Product Code
    QHP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN OVERCORRECTION WAS ORIGINALLY MEASURED AT 11 DEGREES DURING THE PARTICIPANT'S YEAR 3 VISIT ON (B)(6)2024 AND WAS MONITORED UNTIL THE NEXT VISIT. AT THE NEXT VISIT ON (B)(6) 2024 THE MISALIGNMENT WAS RE-EVALUATED AND CHANGED TO REFLECT THE OVERCORRECTION, NOW WORSENED TO 14 DEGREES. PLANNED REVISION SURGERY TO RELEASE TENSION FROM T11 TO L2 TO STOP OVERCORRECTION WAS PLANNED. FOLLOWING THESE FINDINGS, THE PARTICIPANT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2024 FOR A REVISION SURGERY TO REMOVE THE TETHER FROM T11 TO L2. THE PARTICIPANT WAS HOSPITALIZED OVERNIGHT UNTIL (B)(6) 2024 AND WILL RETURN TO CLINIC TO BE MONITORED. THIS EVENT WAS REPORTED TO THE MANUFACTURER VIA (B)(6) PER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965479 VERTEBRAL BODY TETHERING SYSTEM THE TETHER VERTEBRAL BODY TETHERING SYSTEM QHP ZIMVIE / HIGHRIDGE MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention| H