BEUDAMED
    FDA Adverse Event Summary report: N

    OSTEOSHIELD

    MDR report key: 6153413 · Received December 7, 2016

    Report

    Report Number
    2249852-2016-00017
    Date Received
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    UDI-DI
    D716OSCRM15201
    PMA / PMN Number
    K003339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED. COLLAGEN MATRIX, INC. COULD NOT OBTAIN THE PRODUCT LOT NUMBER AND/OR EXPIRATION DATE, THEREFORE FURTHER ASSESSMENT COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    CLINICIAN OBSERVED A FOREIGN BODY REACTION WITH THE USE OF THE MEMBRANE. THE CLINICIAN THOUGHT IT WAS CAUSED BY THE MEMBRANE BUT ALSO MENTIONED PATIENT BORN AND SURGICALLY BORN ISSUES MAY HAVE LED TO WHAT WAS OBSERVED. COMPLAINT STATES THAT THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801393 OSTEOSHIELD COLLAGEN DENTAL MEMBRANE NPL COLLAGEN MATRIX, INC. D716OSCRM15201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other