BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIBSON HEALTHCARE MEMBRANE 3-4

    MDR report key: 25256002 · Received May 22, 2026

    Report

    Report Number
    2249852-2026-00010
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    October 13, 2025
    Report Date
    May 22, 2026
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    PMA / PMN Number
    K141909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED PRE-MATURE RESORPTION OF THE GIBSON HEALTHCARE MEMBRANE 3-4. ON (B)(6) 2025, THE CLINICIAN PREPARED THE AREA FOR BONE GRAFTS. GIBSON HEALTH CARE ALLOGRAFT BONE PARTICULATE (NOT A COLLAGEN MATRIX, INC. PRODUCT) WAS PLACED IN THE EXTRACTION SITES. THE SITE WAS COVERED WITH TWO GIBSON HEALTHCARE MEMBRANES 3-4 (A COLLAGEN MATRIX, INC. PRODUCT). ON A (B)(6) 2025 VISIT, PRIMARY WOUND CLOSURE WAS NOT ACHIEVED. CUSTOMER REPORTED AT THIS VIST, THE MEMBRANES WERE MISSING AND MUCH OF THE GRAFT WAS LOST. THE SURGICAL SITE WAS ALLOWED TO GRANULATE IN AND THE GINGIVA CLOSED SUCCESSFULLY AT (B)(6) 2025 VISIT. HOWEVER DUE TO THE LOSS OF MEMBRANES, MOST OF THE GRAFT MATERIAL WAS LOST AND THERE WAS SIGNIFICANT RIDGE LOSS. MEDICAL INTERVENTION REQUIRED TO ADJUST THE DENTURE ON (B)(6) 2025, (B)(6) 2025 AND (B)(6) 2025. ON (B)(6) 2025, THE CLINICIAN PLACED A TREATMENT RELINE (COE SOFT; NOT A COLLAGEN MATRIX, INC. PRODUCT). ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING PATIENT STATUS, PATIENT OUTCOME, AND IF ANY OF THE APPOINTMENTS WERE REGULARLY SCHEDULED APPOINTMENTS, HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68288 GIBSON HEALTHCARE MEMBRANE 3-4 COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP NPL COLLAGEN MATRIX, INC. 5250-855 PRLU24E1

    Patients

    Seq Age Sex Outcome Treatment
    1