BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGRAFT D GEL 5CC

    MDR report key: 2471873 · Received February 27, 2012

    Report

    Report Number
    2090010-2012-00002
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    MQV
    PMA / PMN Number
    K040419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO. THE DEVICE DIRECTIONS FOR USE INDICATE THAT THE PRODUCT IS FOR SINGLE PT USE ON A SINGLE OCCASION ONLY.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A CLINICIAN REPORTED THE DYNAGRAFT TURNED BLACK AND CRUMBLY AND BONE / TISSUE REGRESSION WAS EVIDENT IN MOST CASES. THE SAME 5CC. WAS USED ON AT LEAST 15 PTS; THE CLINICIAN EXPELS THE AMOUNT REQUIRED FOR EACH CASE, CAPS THE SYRINGE TIP, AND STORES IT FOR FUTURE USE. INTEGRA HAS REQUESTED CLINICAL DETAILS FOR ALL PTS WHO HAD BONE / TISSUE REGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAGRAFT D GEL 5CC DYNAGRAFT MQV ISOTIS ORTHOBIOLOGICS, INC 110762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other