BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

    MDR report key: 15729584 · Received November 4, 2022

    Report

    Report Number
    3001503333-2022-00002
    Event Type
    Injury
    Date Received
    November 4, 2022
    Report Date
    October 26, 2022
    Manufacturer
    ISOTIS ORTHOBIOLOGICS INC.
    Product Code
    MQV
    PMA / PMN Number
    K070751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    POSTSURGICAL INFECTIONS DEVELOPED IN 5 IMPLANTS. IN PATIENT WITH 2 IMPLANTS THAT DEVELOPED AN INFECTION, BONE GRAFT MATERIALS WERE REMOVED. ALL INFECTIONS WERE CURED COMPLETELY WITH ANTIBIOTICS. THE SOURCE OF INFECTION IS UNKNOWN.

    Description of Event or Problem · 0

    A CLINICAL STUDY OF GRAFT MATERIALS USING AUTOGENOUS TEETH IN MAXILLARY SINUS AUGMENTATION WAS PERFORMED IN 2011. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF AUTOGENOUS TOOTH BONE GRAFT MATERIALS. AUTOGENOUS TOOTH BONE GRAFT MATERIALS WERE USED ALONE IN 27 PATIENTS WITH 38 IMPLANTS. IN CASES INVOLVING A MIXTURE OF AUTOGENOUS BONE AND AUTOGENOUS TOOTH BONE GRAFT MATERIALS, AUTOGENOUS BONE WAS HARVESTED PRIMARILY FROM THE MAXILLARY TUBEROSITY. AS FOR SYNTHETIC BONE, OSTEON (GENOSS, KOREA) WAS USED. BONE GRAFT MATERIALS USED AS ALLOGENIC BONE INCLUDED TUTOPLAST (TU-TOGEN MEDICAL, GERMANY), ALLOMATRIX (WRIGHT MEDICAL TECH, INC., ARLING-TON, TN), ORTHOBLAST II (ISOTIS ORTHO-BIOLOGICS, IRVINE, CA), ALLOBT (KOREA TISSUE BANK, KOREA), DBX (SYNTHES, MTF), AND OPTIGRAFT (PURGO TISSUE BANK). AS FOR XENOGENEIC BONES, BIO-OSS (GEISTLICH CO., SWITZERLAND) AND THE BIOCERA (OSCOTEC, KOREA) WERE USED. IN CASES INVOLVING FAMILIAL TOOTH BONE GRAFT MATERIALS PREPARED FROM TEETH EXTRACTED FROM FAMILY MEMBERS, THE NUMBER OF IMPLANTS PLACED WAS 2. IT WAS REPORTED THAT POSTSURGICAL INFECTIONS HAD DEVELOPED IN 5 IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784387 ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY DEMINERALIZED BONE MATRIX PASTE AND PUTTY MQV ISOTIS ORTHOBIOLOGICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ALLOBT| ALLOMATRIX| BIO-OSS| BIOCERA| DBX| OPTIGRAFT| OSTEON| TUTOPLAST