BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIX BONE

    MDR report key: 12213409 · Received July 22, 2021

    Report

    Report Number
    1222802-2021-00001
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 22, 2021
    Product Code
    LPK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, A (B)(6) YEARS OLD FEMALE PATIENT RECEIVED A BONEGRAFT WITH OSSIX BONE 5*10*10 (0.5CC) IN POSITION 30 (FDI 46) ON (B)(6) 2021. THE BONEGRAFT WAS REMOVED ON (B)(6) 2021 AS IT DID NOT INTEGRATE. THE BONEGRAFT NEVER INTEGRATED, IT WAS LOST (ALMOST REJECTED) FROM THE EXTRACTION SITE. THE PATIENT RETURNED FOUR DAYS LATER WITH SWELLING AND ALMOST FOOD IMPACTION/DRY SOCKET SYMPTOMS. THE OSSIX BONEGRAFT PARTIALLY "FLAKED" OUT AND WAS ACTING MORE AS A FOREIGN BODY THAN INTEGRATING. IT WAS SUCTIONED OUT AT TIME OF DEBRIDEMENT. THERE ARE A NUMBER OF WELL-KNOWN COMPLICATIONS USING BONEGRAFT TECHNIQUES. THIS EVENT IS REPORTABLE PER 21 CFR PART 803 AS DENTSPLY SIRONA IMPLANTS IS THE IMPORTER FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109744 OSSIX BONE BONE GRAFTING MATERIAL, FOR DENTAL BONE REPAIR LPK NA OB50000142

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention