BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIAMI JR OCCIAN BACK

    MDR report key: 10940008 · Received December 3, 2020

    Report

    Report Number
    10940008
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 13, 2020
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    A PATIENT SUSTAINED MULTIPLE TRAUMATIC INJURIES INCLUDING BRAINSTEM INFARCT AND CRANIOCERVICAL DISSOCIATION FROM A HIGH SPEED MOTOR VEHICLE COLLISION. DUE TO ABNORMAL INTRACRANIAL PRESSURE VARIATION, USUAL HEAD MOVEMENT WITHIN THE C COLLAR WAS COMPLETELY RESTRICTED AND THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY UNDER THE CHIN.

    Description of Event or Problem · 0

    A PATIENT SUSTAINED MULTIPLE TRAUMATIC INJURIES INCLUDING BRAINSTEM INFARCT AND CRANIOCERVICAL DISSOCIATION FROM A HIGH SPEED MOTOR VEHICLE COLLISION. DUE TO ABNORMAL INTRACRANIAL PRESSURE VARIATION, USUAL HEAD MOVEMENT WITHIN THE C COLLAR WAS COMPLETELY RESTRICTED AND THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY UNDER THE CHIN.

    Description of Event or Problem · 0

    A PATIENT SUSTAINED MULTIPLE TRAUMATIC INJURIES INCLUDING BRAINSTEM INFARCT AND CRANIOCERVICAL DISSOCIATION FROM A HIGH SPEED MOTOR VEHICLE COLLISION. DUE TO ABNORMAL INTRACRANIAL PRESSURE VARIATION, USUAL HEAD MOVEMENT WITHIN THE C COLLAR WAS COMPLETELY RESTRICTED AND THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY UNDER THE CHIN.

    Description of Event or Problem · 0

    A PATIENT SUSTAINED MULTIPLE TRAUMATIC INJURIES INCLUDING BRAINSTEM INFARCT AND CRANIOCERVICAL DISSOCIATION FROM A HIGH SPEED MOTOR VEHICLE COLLISION. DUE TO ABNORMAL INTRACRANIAL PRESSURE VARIATION, USUAL HEAD MOVEMENT WITHIN THE C COLLAR WAS COMPLETELY RESTRICTED AND THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY UNDER THE CHIN.

    Description of Event or Problem · 1

    A PATIENT SUSTAINED MULTIPLE TRAUMATIC INJURIES INCLUDING BRAINSTEM INFARCT AND CRANIOCERVICAL DISSOCIATION FROM A HIGH SPEED MOTOR VEHICLE COLLISION. DUE TO ABNORMAL INTRACRANIAL PRESSURE VARIATION, USUAL HEAD MOVEMENT WITHIN THE C COLLAR WAS COMPLETELY RESTRICTED AND THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY UNDER THE CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403624 MIAMI JR OCCIAN BACK ORTHOSIS, CERVICAL IQK OSSUR AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other