BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON XENOGRAFT GRANULES 0.5 ML

    MDR report key: 5554144 · Received April 7, 2016

    Report

    Report Number
    3006946279-2016-00037
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    October 14, 2015
    Report Date
    September 16, 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
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PMA 510(K) - 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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CORRECTIVE ACTION WAS INITIATED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORAL BONE GRAFTING PROCEDURE ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT DEVELOPED INFLAMMATION AND THE SURGEON IMPLANTED AN ADDITIONAL BONE GRAFT AS A HOLE WAS DISCOVERED IN THE IMPLANT AREA ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215248 ENDOBON XENOGRAFT GRANULES 0.5 ML BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0025170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention