BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON XENOGRAFT GRANULES

    MDR report key: 6116520 · Received November 21, 2016

    Report

    Report Number
    3006946279-2016-00442
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    June 5, 2016
    Report Date
    November 20, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PK110449
    Removal / Correction Number
    FR 2015-03
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTION HAS BEEN INITIATED FOR THE REPORTED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.(B)(4).

    Description of Event or Problem · 1

    PATIENT'S BONE GRAFT WAS REMOVED APPROXIMATELY 12 MONTHS POST-IMPLANTATION DUE TO OSSEOINTEGRATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769649 ENDOBON XENOGRAFT GRANULES BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0124272

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention