BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVASIS DRILL GUIDE

    MDR report key: 10810014 · Received November 6, 2020

    Report

    Report Number
    MW5097699
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 4, 2020
    Manufacturer
    INNOVASIS
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CERVICAL SPINE SURGERY THE INNOVASIS SA467 OPTERYX DRILL GUIDE BIT BROKE OFF. APPROXIMATELY 1.5CM OF THE DRILL BIT WAS RETAINED. NO HARM TO THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262894 INNOVASIS DRILL GUIDE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ INNOVASIS SA467

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR