BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAUMANN BONE CERAMIC

    MDR report key: 2256883 · Received September 16, 2011

    Report

    Report Number
    1222315-2011-00041
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 16, 2011
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    LYC
    PMA / PMN Number
    K040646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION. THE (B)(6) 2011 IMPLANT REMOVAL OF THIS REPORT WILL BE REPORTED ON THE NEXT QUARTERLY STRAUMANN TO FDA, SCHEDULED DUE ON OCTOBER 31, 2011.

    Description of Event or Problem · 1

    CLINICIAN REPORTS SURGERY (B)(6) 2011 IMPLANTATION REGION 22 WITH ARTICLE 021.4110 LOT X0766 WITH BONE CERAMIC 070.203 LOT P0354 AND BIOGIDE 100327. ON (B)(6) 2011, ALL SUTURES ARE OPEN SLIGHTLY BECAUSE A SUTURE WAS BROKEN. ON (B)(6) 2011, AT CONTROL CHECK-UP A 3MM POCKET BUCCALLY AROUND THE IMPLANT WAS DISCOVERED - CAUSE UNK. ON (B)(6) 2011, AT IMPRESSION TAKING THE IMPLANT ROTATED WHEN INSERTING THE CLOSURE SCREW. THE IMPLANT WAS REMOVED. ON (B)(6) 2011, THE GINGIVA WAS OPEN - THERE WAS BONE DEFECT WITH INFLAMED TISSUE. THE REMAINS OF BONE CERAMIC AND GRANULATION TISSUE WAS REMOVED. PT WAS TREATED WITH MEFENACID AND PLACK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAUMANN BONE CERAMIC SYNTHETIC BONE GRAFTING MATERIAL LYC INSTITUT STRAUMANN AG P0354

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention