BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX SUTURABLE

    MDR report key: 23794895 · Received December 12, 2025

    Report

    Report Number
    2249852-2025-00060
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    July 4, 2024
    Report Date
    December 12, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    UDI-DI
    00813954020402
    PMA / PMN Number
    K141608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED OUTSIDE THE STANDARD 30-DAY REPORTING TIMEFRAME DUE TO CORRECTIVE ACTIONS TAKEN FOLLOWING A NONCONFORMITY IDENTIFIED DURING AN MDSAP AUDIT /INSPECTION.

    Description of Event or Problem · 0

    THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILARLY MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. LIMITED INFORMATION SURROUNDING THE EVENT WAS PROVIDED. THE CUSTOMER INFORMED THE MANUFACTURER THAT THE DURAMATRIX SUTURABLE PRODUCT WAS UTILIZED ON A PATIENT DURING AN INITIAL SURGERY ON (B)(6) 2023. 7 MONTHS AFTER THE INITIAL SURGERY, REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 AND IT WAS FOUND THAT THE DURAMATRIX SUTURABLE PATCH DID NOT RESORB. THE PATCH "WAS ALMOST INTACT." THE FOLLOWING INFORMATION WAS REQUESTED BUT NOT PROVIDED: INFORMATION SURROUNDING THE INITIAL SURGERY (INCLUDING NATURE OF SURGERY), REASON FOR THE REVISION SURGERY, SURGICAL TECHNIQUE INFORMATION, CURRENT PATIENT STATUS, AND IF THERE ARE ANY FOLLOW-UP VISITS SCHEDULED. REVISION SURGERY WAS REQUIRED FOR THE PATIENT, HOWEVER DETAILS SURROUNDING THE REASON FOR THE REVISION SURGERY WERE NOT PROVIDED. INFORMATION SURROUNDING PATIENT STATUS WAS REQUESTED BUT NOT PROVIDED. COMPLAINANT CONFIRMED THE PATIENT "DID NOT FEEL ANY DISCOMFORT CAUSED BY THE PATCH. THE FOLLOWING INFORMATION WAS REQUESTED: INFORMATION SURROUNDING THE INITIAL SURGERY, REASON FOR THE REVISION SURGERY, SURGICAL TECHNIQUE INFORMATION, CURRENT PATIENT STATUS, AND IF THERE ARE ANY FOLLOW-UP VISITS SCHEDULED. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION HOWEVER NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703804 DURAMATRIX SUTURABLE COLLAGEN DURA MEMBRANE GXQ COLLAGEN MATRIX, INC. DMS22 2307281121 00813954020402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O