BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA SUBSTITUTE

    MDR report key: 7035718 · Received November 15, 2017

    Report

    Report Number
    2249852-2017-00020
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SEVERAL FOLLOW-UP ATTEMPTS, COLLAGEN MATRIX, INC. WAS NOT ABLE TO OBTAIN ADDITIONAL PRODUCT IDENTIFICATION INFORMATION SUCH AS PRODUCT TRADE NAME, REFERENCE NUMBER OR UDI CODE. AS A RESULT A COMPREHENSIVE INVESTIGATION COULD NOT BE PERFORMED. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL PRODUCT INFORMATION BECOMES AVAILABLE TO COLLAGEN MATRIX, INC.

    Description of Event or Problem · 1

    IN REGARDS TO AN UNIDENTIFIED DURAMATRIX PRODUCT, THE CLINICIAN STATED THAT "ON REVISION/CRANIOPLASTY IT APPEARS THAT NOTHING WAS LEFT ON THE BRAIN" THE PRODUCT DOESN'T APPEAR TO HELP MAINTAIN THE BRAIN/GALEA/PERICRANIUM PLANE. CLINICIANS ARE CONCERNED THAT SUCH EVENTS MAY RESULT IN PROLONGED HOSPITAL STAYS IF THE SURGERIES ARE MORE DIFFICULT IF THERE IS NOT A CLEAR PLANE TO DISSECT ONTO. TO DATE, NO PATIENT ADVERSE EVENTS HAVE BEEN REPORTED TO COLLAGEN MATRIX, INC. AS PART OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814520 DURA SUBSTITUTE GXQ COLLAGEN MATRIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization