BEUDAMED
    FDA Adverse Event Other Summary report: N

    DBP PUTTY 1CC

    MDR report key: 1353565 · Received March 19, 2009

    Report

    Report Number
    2090010-2009-00001
    Event Type
    Other
    Date Received
    March 19, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 19, 2009
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC.
    Product Code
    LYC
    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 EVALUATION. AN INVESTIGATION WAS INITIATED BASED UPON THE REPORTED INFORMATION. A REVIEW OF THE BATCH RECORD FOR THE AFFECT LOT 081054, INDICATED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE FINISHED PRODUCT SPECIFICATIONS. THERE WERE NO NON-CONFORMITY REPORTS INITIATED. THE ARCHIVE RETAIN SAMPLE WAS VISUALLY INSPECTED AS SATISFACTORY. THE DEMINERALIZATION BATCH RECORD, LOT 805097, WAS REVIEWED FOR BMP-2 CONTENT USING THE ELISA METHOD. RESULTS MET SPECIFICATION, INDICATING BMP-2 CONTENT RESULT WAS 6.83NG/G ACCEPTANCE CRITERIA IS >4.91NG/G. THE DONOR RECORD (B)(6) WAS ALSO REVIEWED, WHICH INDICATED ACCEPTABLE DONOR ELIGIBILITY. IN A REVIEW OF THE DESCRIPTION OF THE OCCURRENCE FROM (B)(6) COMPLAINT (B)(4), WHICH STATED "COMPLETE FAILURE OF GRAFT TO UNIONIZE TO HOST BONE AFTER FOUR MONTHS.", INTEGRA OBSERVED THAT THE GRAFT WAS ONLY IN PLACE FOR 4 MONTHS, WHICH IS NOT ADEQUATE TIME ALLOW THE BONE TO HEAL. ACCORDINGLY TO THE DIRECTIONS FOR USE, THE GRAFT REQUIRES APPROXIMATELY 6 MONTHS TO HEAL. THE PRODUCT GRAFT WAS NOT IMPLANTED IN ACCORDANCE TO THE DIRECTIONS FOR USE. THE DYNABLAST DIRECTIONS FOR USE, SECTION WARNINGS AND PRECAUTIONS, SPECIFIES THE FOLLOWING STATEMENT: "SITES GRAFTED WITH DYNABLAST SHOULD BE ALLOWED TO HEAL APPROXIMATELY 6 MONTHS PRIOR TO IMPLANT PLACEMENT." INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT WAS RECEIVING TREATMENT FOR A MISSING TOOTH AND ATROPHIC RIDGE. THERE WAS A COMPLETE FAILURE OF THE GRAFT TO UNIONIZE TO THE HOST BONE AFTER FOUR MONTHS. THE GRAFT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBP PUTTY 1CC NA LYC ISOTIS ORTHOBIOLOGICS, INC. 081054

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention DYNAMATIRX MEMBRANE| ETHICON SUTURES