BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOGUARD FLEX

    MDR report key: 23794916 · Received December 12, 2025

    Report

    Report Number
    2249852-2025-00065
    Event Type
    Injury
    Date Received
    December 12, 2025
    Report Date
    December 12, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    PMA / PMN Number
    K090216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. COMPLAINT RECEIVED THROUGH CLINICAL DATA COLLECTION. AN OSSEOGUARD FLEX MEMBRANE, REF NO. OGF1520, WAS UTILIZED DURING A PROCEDURE FOR FILLING OF BONE DEFECTS AFTER ROOT RESECTION, CYSTECTOMY OR REMOVAL OF RETAINED TEETH AT SITE 21/22. THE CLINICIAN REPORTED THE ADVERSE EVENT AS "LOSS OF BONE GRAFT MATERIAL". THE MEMBRANE WAS HYDRATED PRIOR TO PLACEMENT WITH STERILE SALINE. ENDOBON BONE GRAFT MATERIAL WAS ALSO USED. (NOT A COLLAGEN MATRIX, INC. PRODUCT). STABILIZED WITH SUTURES 5.0 CORALENE. PRIMARY CLOSURE WAS ACHIEVED. DENTAL IMPLANT NOT PLACED: DENTAL BRIDGE IS PREFERRED BECAUSE OF AESTHETICS AND PREDICTABILITY. NO OTHER PRODUCTS WERE USED, NO COMPLICATIONS OCCURRED DURING IMPLANTATION AND NO OTHER CONCOMITANT MEDICAL TREATMENT WAS PERFORMED. POST-OPERATIVE INSTRUCTIONS INCLUDED ANTIMICROBIAL ORAL RINSE: PERIO-AID. FOLLOW-UP VISIT WAS (B)(6) 2023 FOR THE ASSESSMENT OF BONE GRAFT OUTCOME. WOUND HEALING WAS UNEVENTFUL. NO SURGICAL/MEDICAL INTERVENTION WAS REQUIRED. PERIODONTAL DEFECT REGENERATION WAS SUCCESSFUL. NO OTHER PATIENT INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759197 OSSEOGUARD FLEX COLLAGEN DENTAL MEMBRANE IV NPL COLLAGEN MATRIX, INC. OGF1520 BDMU22A1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other