BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIX BONE, OSSIX PLUS

    MDR report key: 14779540 · Received June 22, 2022

    Report

    Report Number
    3010626093-2022-00002
    Event Type
    Injury
    Date Received
    June 22, 2022
    Report Date
    June 22, 2022
    Manufacturer
    DATUM DENTAL LTD.
    Product Code
    NPM
    PMA / PMN Number
    K163714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTS INVOLVED: OSSIX BONE (K163714, NPM) - BATCH #OB25000231, EXP DATE 10/25/2024, UDI (B)(4) ; OSSIX BONE (K163714,, NPM) - BATCH #OB50000183, EXP DATE 04/06/2024 , UDI (B)(4) OSSIX PLUS (K160281, NPL) - BATCH # OP1500472, EXP DATE 11/14/2024, UDI (B)(4).

    Description of Event or Problem · 0

    PATIENT HAS RECEIVED 3 ROUNDS OF ANTIBIOTICS THROUGHOUT THE PROCESS. CASES HAVE BEEN VIGOROUSLY CURETTED AND FLUSHED. THE CASES WERE DEEMED FAILURES BECAUSE THE FIRST ONE CAME OUT, AND THERE WAS SEVERE PAIN DIRECTLY ON THE SECOND GRAFT WHEN TOUCHED WITH AN INSTRUMENT. THE TOOTH WAS EXTRACTED ON 4/4 AND 2 OSSIX BONE GRAFTS AND 1 OSSIX MEMBRANE WERE USED. THOSE FAILED AND WERE REPLACED ON 4/14 WITH JUST OSSIX BONE (NO MEMBRANE). ON THE 10TH THAT BONE WAS PULLED OUT AND REPLACED WITH CORTICAL BONE AND AN OSSIX MEMBRANE. THERE IS CONCERN AGAIN ABOUT THE BUBBLING OF THE MEMBRANE. THE DOCS JUST WENT TO CDOCS AND GOT MORE OSSIX TRAINING SO FEEL THAT ALL WAS DONE CORRECTLY. THEY EVEN SWITCHED FROM USING VICRYL SUTURES TO CHROMIC GUT PER THE COURSE RECOMMENDATION. THE PATIENT IS A 38 YEAR OLD NON-SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982109 OSSIX BONE, OSSIX PLUS BONE GRAFTING MATERIAL, ANIMAL SOURCE NPM DATUM DENTAL LTD. OSSIX BONE - 5X5X10, 5X10X10 MM, OSSIX PLUS - 15X25 OB25000231,OB50000183,OP150047

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown Other ANTIBIOTICS