BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPLANT

    MDR report key: 1425508 · Received August 3, 2009

    Report

    Report Number
    2024312-2009-00046
    Event Type
    Injury
    Date Received
    August 3, 2009
    Report Date
    July 7, 2009
    Manufacturer
    KERR CORPORATION
    Product Code
    LYC
    PMA / PMN Number
    K050984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR IDENTIFIED TWO LOTS ASSOCIATED WITH THE 3 ALLEGED INCIDENTS. IT IS UNCLEAR WHICH LOT OF PRODUCT WAS USED ON EACH PATIENT. NUMEROUS ATTEMPTS WERE MADE TO GET IN CONTACT WITH THE DOCTOR. UNFORTUNATELY THEY HAVE REMAINED UNRESPONSIVE AND NO ADDITIONAL INFORMATION REGARDING THE PATIENTS OR INCIDENTS COULD BE OBTAINED. MANUFACTURE DATES: ITEM # LOT G8410-35: JUNE 2008; ITEM # LOT B8920-30: JULY 2008. THE ACTUAL DEVICES INVOLVED IN THESE INCIDENTS WERE NOT RETURNED TO KERR CORPORATION; THEREFORE, NO EVALUATION ON THE ACTUAL DEVICES COULD BE CONDUCTED. PRODUCTION RECORDS SHOW THAT THE PRODUCT MET RELEASE SPECIFICATIONS. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED. THIS MDR IS BEING SUBMITTED DUE TO THE ALLEGATION THAT INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY. THIS IS THE SECOND MDR REPORT OF THE THREE INCIDENTS REPORTED.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR REPORTED THAT THREE (3) PATIENTS RETURNED TO THE OFFICE WITH DRY SOCKET PAIN. THE DOCTOR HAD TO REMOVE THE BIOPLANT AND REPLACE IT WITH DRY SOCKET MEDICATIONS IN ORDER TO RELIEVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLANT BONE GRAFTING MATERIAL LYC KERR CORPORATION G8410-35 AND B8920-30

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention