BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTGRAFT GRANULES

    MDR report key: 23812050 · Received December 15, 2025

    Report

    Report Number
    2249852-2025-00054
    Event Type
    Injury
    Date Received
    December 15, 2025
    Report Date
    December 15, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPM
    UDI-DI
    00813954023830
    PMA / PMN Number
    K140714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED OUTSIDE OF THE STANDARD 30-DAY REPORTING TIMEFRAME DUE TO CORRECTIVE ACTIONS TAKEN FOLLOWING A NON-CONFORMITY IDENTIFIED DURING AN MDSAP AUDIT / INSPECTION. ANALYSIS OF PRODUCTION RECORDS CONFIRMED ALL NON-ROUTINE AND ROUTINE TESTING PERFORMED AT TIME OF RELEASE MET ACCEPTANCE CRITERIA AS SPECIFIED IN PRODUCT SPECIFICATIONS. NO ADDITIONAL TESTING COULD BE PERFORMED THAT WOULD DIRECTLY CORRELATE WITH THE ISSUE IDENTIFIED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILAR MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. AT TIME OF COMPLAINT INITIATION, THE CUSTOMER REPORTED A DEHISCENCE WAS OBSERVED IN A PATIENT AFTER THE APPLICATION OF SMARTGRAFT IN COMBINATION WITH SMARTBRANE (NOT A COLLAGEN MATRIX, INC. PRODUCT) IN THE ANTERIOR AREA. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME. CUSTOMER LATER PROVIDED ADDITIONAL INFORMATION SURROUNDING THE INCIDENT. A GENERALLY HEALTHY FEMALE PATIENT UNDERWENT GUIDED BONE REGENERATION SURGERY ON (B)(6) 2023, IN WHICH THE SMARTGRAFT PRODUCT WAS UTILIZED FOR FILLING A "CUSTOMER-MADE TITANIUM MESH EXTRA-ORALLY" AND WAS COMBINED "WITH CROSS-LINKED HYALURONIC ACID AND AUTOLOGOUS BONE IN A 70%-30% RATIO. MEMBRANES WERE PLACED OVER THE MESH, PARTIALLY OVERLAPPING ONE ANOTHER. THE MEMBRANES USED WERE NOT A COLLAGEN MATRIX, INC. PRODUCT. THERE WERE NO COMPLICATIONS NOTED DURING THIS INITIAL PROCEDURE. A FOLLOW-UP VISIT WAS CONDUCTED ON (B)(6) 2023 AND A MESH EXPOSURE MEASURING 4MM WIDE WAS OBSERVED. NO SIGNIFICANT PAIN OR INFECTIONS REPORTED. SUPERFICIALIZATION OF SOME GRANULES OF THE GRAFTED MATERIAL WAS NOTED. INTERVENTAION REQUIRED AS A CUTTER WAS USED TO REMOVE EXPOSED PORTION OF THE MESH. NO SIGNS OF INFECTION NOTED. THERE WAS DISPERSION OF GRAFTED MATERIAL, WITH SUPERFICIAL GRANULES BEING REMOVED AS THEY SURFACED. ANOTHER FOLLOW-UP EXAM WAS CONDUCTED ON (B)(6) 2023. PATIENT'S CLINICAL CONDITION WAS STABLE. THE EXPOSED AREA WAS RINSED WITH A 0.9% SALINE SOLUTION, AND ADDITIONAL MIGRATED GRAFTED GRANULES WERE REMOVED. MODERATE INFLAMMATION NOTED AT SITE OF EXPOSURE, BUT NO SIGNS OF INFECTION OR PAIN. THE PATIENT RETURNED ON (B)(6) 2023 FOR A CONE BEAM COMPUTED TOMOGRAPHY AND PATIENT UNDERWENT A ROUTINE EXAMINATION. PATIENT'S CONDITION WAS STABLE. IT WAS NOTED A FEW GRANULES HAD SURFACED AND WERE REMOVED AS PART OF THE ONGOING MANAGEMENT. CUSTOMER CONFIRMED A COMPLETE REMOVAL OF THE MESH IS SCHEDULED FOR (B)(6) 2024. PATIENT HAS BEEN INSTRUCTED TO APPLY AMINOGAM AT HOME. ADDITIONAL INFORMATION SURROUNDING THE FOLLOW-UP AND PATIENT STATUS WAS REQUESTED BUT NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324133 SMARTGRAFT GRANULES PORCINE ANOGRANIC BONE MINERAL NPM COLLAGEN MATRIX, INC. 114.101 PMCU20P1 00813954023830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R