BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON® XENOGRAFT GRANULES 0.5ML

    MDR report key: 5572985 · Received April 13, 2016

    Report

    Report Number
    3006946279-2016-00043
    Event Type
    Injury
    Date Received
    April 13, 2016
    Report Date
    March 18, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DATE OF EVENT - UNKNOWN, EXPLANT DATE - UNKNOWN. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K110449.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORAL BONE GRAFTING PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE BONE GRAFT WAS REMOVED ON AN UNKNOWN DATE DUE TO AN UNKNOWN REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228529 ENDOBON® XENOGRAFT GRANULES 0.5ML BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0171316

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R