BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPLANT

    MDR report key: 1288723 · Received January 16, 2009

    Report

    Report Number
    2024312-2009-00002
    Event Type
    Injury
    Date Received
    January 16, 2009
    Report Date
    January 5, 2009
    Manufacturer
    KERR CORPORATION
    Product Code
    LYC
    PMA / PMN Number
    K050984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENTS ARE DOING FINE. THE ACTUAL DEVICES INVOLVED IN THESE INCIDENT WERE NOT RETURNED TO KERR CORPORATION FOR EVALUATION. ADDITIONALLY, THE DOCTOR DID NOT PROVIDE ANY LOT NUMBER INFORMATION; THEREFORE NO EVALUATIONS COULD BE PERFORMED. THIS IS THE SECOND MDR REPORT OF THE FIVE INCIDENTS REPORTED.

    Description of Event or Problem · 1

    IN EARLY 2009, A DOCTOR REPORTED TO KERR CORPORATION THAT FOUR PATIENTS LOST DENTAL IMPLANTS AS A RESULT OF A GRANULOMATOUS INFLAMMATORY RESPONSE FROM USE OF THE BIOPLANT BONE GRAFT MATERIAL FOR AUGMENTATION OF BUCCAL PLATES DURING THE IMPLANT INSERTIONS. THE DOCTOR REPORTED THAT A FIFTH PATIENT REQUIRED MEDICAL INTERVENTION TO REPLACE THE BIOPLANT WITH A DIFFERENT PRODUCT TO PREVENT THE DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLANT BONE GRAFTING MATERIAL LYC KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other