BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON GRANULES

    MDR report key: 6344050 · Received February 20, 2017

    Report

    Report Number
    3006946279-2017-00045
    Event Type
    Injury
    Date Received
    February 20, 2017
    Report Date
    June 20, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PK110449
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - NI. EXPIRATION DATE ¿ NI. DATE IMPLANTED - NI. MANUFACTURE DATE ¿ NI. 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, 5 PATIENTS EXPERIENCED INFECTION WITHIN TWO WEEKS OF SURGERY DURING WHICH A DENTAL IMPLANT AND GRANULES WERE IMPLANTED. THE PATIENTS WERE TREATED WITH DRAINAGE AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126056 ENDOBON GRANULES BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention