BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADD VBR SMALL

    MDR report key: 8654407 · Received May 29, 2019

    Report

    Report Number
    MW5086978
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    January 22, 2016
    Report Date
    May 24, 2019
    Manufacturer
    ULRICH MEDICAL USA, INC.
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LITERATURE REPORTS FOLLOWING C6 ANTERIOR CERVICAL CORPECTOMY AND FUSION INVOLVING AN EXPANDABLE LORDOTIC CAGE ADD PLUS VBR [K09841]. PATIENT SUFFERED DEVICE-RELATED CERVICOBRACHIALGIA REQUIRING REVISION SURGERY. IMAGING STUDIES REVEAL THE DEVICE CENTER EXPANDABLE STRUT BROKE, CAUSING INJURY AND NEED FOR REVISION. DEVICE INDICATION AND LABELING CLEARED ONLY FOR NON-CERVICAL USES. YET DEVICE CONSTRUCT AND DESIGN RATIONALE CONFIGURED TO CONFORM FOR CERVICAL USE WHICH IS NOT WITHIN THE SCOPE OF THE 510K INTENDED USE AND INDICATION [TRIEB, KLEMENS, AND STEPHAN KOCH. "FAILURE OF AN EXPANDABLE CAGE PLATE CERVICAL VERTEBRAL BODY REPLACEMENT: CASE REPORT OF A DEVICE RELATED COMPLICATION." JOINT DISEASE AND RELATED SURGERY 28.3 (2017): 214-218]. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443090 ADD VBR SMALL SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP ULRICH MEDICAL USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R| S