BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON® XENOGRAFT GRANULES 1.0ML

    MDR report key: 5669650 · Received May 20, 2016

    Report

    Report Number
    3006946279-2016-00081
    Event Type
    Injury
    Date Received
    May 20, 2016
    Date of Event
    November 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
    FR 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. 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. USED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UDI: (B)(4). CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED NO BONE FORMATION, MOBILITY, AND LOSS OF GRANULES SIX MONTHS POST-IMPLANTATION OF AN ORAL BONE GRAFT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325080 ENDOBON® XENOGRAFT GRANULES 1.0ML BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0102251

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other