BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAUMANN BONE CERAMIC

    MDR report key: 2143098 · Received June 23, 2011

    Report

    Report Number
    1222315-2011-00011
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BIORA AB
    Product Code
    NPK
    PMA / PMN Number
    K082111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Z8930 AND STRAUMANN BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203, BATCH Y0263. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT HAD INFECTION AND FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAUMANN BONE CERAMIC SYNTHETIC BONE GRAFTING MATERIAL NPK BIORA AB Y0263

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention