BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOLITH

    MDR report key: 6728303 · Received July 18, 2017

    Report

    Report Number
    MW5071101
    Event Type
    Injury
    Date Received
    July 18, 2017
    Date of Event
    June 28, 2016
    Report Date
    July 18, 2017
    Manufacturer
    NUVASIVE
    Product Code
    MQP
    UDI-DI
    00887517677365
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE-RELATED FAILURE OF MODULAR (STACKABLE) MONOLITH (B)(4) PROCODE MQP RESULTING IN SERIOUS NEUROCOMPROMISE RENDERING PATIENT PARALYZED FOLLOWING SINGLE-LEVEL C6 ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF). PATIENT REQUIRED POSTERIOR REVISION SURGERY POST-OP SIX MONTHS AND IS RELEARNING TO WALK AGAIN. THE MONOLITH DEVICE WAS EXPLICITLY CLEARED FOR USE BELOW THE NECK IN THE THORACOLUMBAR SPINE, BUT IS IN LORDOTIC CAGE GEOMETRY AND DESIGN RATIONALE INTENDED FOR USE IN THE CERVICAL SPINE AND CANNOT POSSIBLY BE USED FOR ITS LABELED PURPOSE. DEVICE COMPONENT PART NUMBERS INCLUDE: 5991220, 5991153, 5992537.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500980 MONOLITH MONOLITH MQP NUVASIVE 5992537 00887517677365
    500981 MONOLITH MONOLITH MQP NUVASIVE 5991220 00887517677365
    500982 MONOLITH MONOLITH MQP NUVASIVE 5991153 00887517677365

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R| S