BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON XENOGRAFT GRANULES 0.5ML

    MDR report key: 6216309 · Received December 30, 2016

    Report

    Report Number
    3006946279-2016-00472
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    October 14, 2016
    Report Date
    May 26, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PK980679
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    PATIENT WAS REPORTED TO HAVE POSSIBLE INFECTION OF DENTAL BONE GRAFT APPROXIMATELY THREE MONTHS POST-IMPLANTATION. THE BONE GRAFT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865888 ENDOBON XENOGRAFT GRANULES 0.5ML BONE GRAFTING MATERIAL LYC BIOMET FRANCE S.A.R.L. N/A U0181349

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other