BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY GRAFT

    MDR report key: 14492220 · Received May 24, 2022

    Report

    Report Number
    2249852-2022-00006
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    August 23, 2021
    Report Date
    June 30, 2022
    Manufacturer
    COLLAGEN MATRIX, INC
    Product Code
    LYC
    PMA / PMN Number
    K131385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT SUBMITTED DUE TO ADDITIONAL INFORMATION PROVIDED ON 06/02/2022.

    Description of Event or Problem · 0

    BASED OFF LIMITED INFORMATION PROVIDED, IT WAS REPORTED THAT A CLINICIAN USED EASY GRAFT ON A PATIENT TO GRAFT AN EXTRACTION SITE AND WHEN THEY WENT BACK IN TO PLACE THE IMPLANT, THE SITE WAS FULL OF GRANULES. THE SITE WAS CLEANED OUT, PROCESS REPEATED, AND THE SAME RESULT OCCURRED. THE CLINICIAN WAS TOLD BY THEIR DISTRIBUTOR REPRESENTATIVE THAT THEY COULD BACK INTO THE SITE AFTER FOUR MONTHS TO PLACE THE IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLINICIAN USED EASY GRAFT ON A PATIENT DURING A SOCKET GRAFT FOR IMPLANT PLACEMENT PROCEDURE AND THE BONE DID NOT TURN OVER AND RESORB. THE CLINICIAN PLACED A GUIDOR EASY GRAFT CLASSIC IN THE PATIENT ON (B)(6) 2021. THE FIRST TIME THE PRODUCT ADHERED TO THE TISSUES. HOWEVER, FOR THE SECOND TIME THE PRODUCT WAS ALL PARTICULATE AND LARGE DEFECT. THE CLINICIAN WENT BACK IN AT ABOUT THREE MONTHS BOTH TIMES. THE CLINICIAN WAS TOLD BY THEIR DISTRIBUTOR REPRESENTATIVE THAT THEY COULD GO BACK INTO THE SITE AFTER FOUR MONTHS TO PLACE THE IMPLANT. THE CLINICIAN REPORTED THAT AFTER TWO GUIDOR FAILURES, MINEROSS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171434 EASY GRAFT BONE GRAFTING MATERIAL, SYNTHETIC LYC COLLAGEN MATRIX, INC 21085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O