BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON® XENOGRAFT GRANULES 1.0ML

    MDR report key: 5669528 · Received May 20, 2016

    Report

    Report Number
    3006946279-2016-00080
    Event Type
    Injury
    Date Received
    May 20, 2016
    Date of Event
    December 1, 2015
    Report Date
    April 20, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    2015-03
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    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. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI. 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. CORRECTIVE ACTION HAS BEEN INITIATED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED NO BONE FORMATION SIX MONTHS POST-IMPLANTATION OF AN ORAL BONE GRAFT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324032 ENDOBON® XENOGRAFT GRANULES 1.0ML BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0171316

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other