BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON XENOGRAFT GRANULES

    MDR report key: 6345689 · Received February 21, 2017

    Report

    Report Number
    3006946279-2017-00046
    Event Type
    Injury
    Date Received
    February 21, 2017
    Report Date
    January 23, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. LEE ET AL. "A RETROSPECTIVE STUDY OF COMPLICATIONS ASSOCIATED WITH 100 CONSECUTIVE MAXILLARY SINUS AUGMENTATIONS VIA THE LATERAL WINDOW APPROACH" THE INTERNATIONAL JOURNAL OF ORAL & MAXILLOFACIAL IMPLANTS (2013) 28:860-868.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, ONE PATIENT EXPERIENCED EXCESSIVE BONE RESORPTION 6 MONTHS POST-OPERATIVELY. POSSIBLE SMALL SINUS MEMBRANE PERFORATIONS DURING BONE GRAFT PACKING, SNEEZING, OR BLOWING THE NOSE AT THE INITIAL STAGE OF HEALING, OR INCOMPLETE ELEVATION OF THE SINUS MEMBRANE FROM THE MEDIAL WALL OF THE SINUS MAY HAVE CAUSED THE BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127640 ENDOBON XENOGRAFT GRANULES BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other