BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 8.0ML

    MDR report key: 5722480 · Received June 14, 2016

    Report

    Report Number
    3006946279-2016-00110
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    May 13, 2014
    Report Date
    September 21, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    FR 2015-03
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THIS DEVICE IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN U.S. MANUFACTURES A SIMILAR PRODUCT UNDER 510K NUMBER K110449. (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ORAL BONE GRAFTING PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A PERIODONTAL PROCEDURE DUE TO NON-INTEGRATION, INFECTION, BONE LOSS, NON-HEALING WOUND AND GINGIVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376770 ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 8.0ML BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A T0292043

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R