BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRAUMANN BONE CERAMIC

    MDR report key: 787409 · Received November 17, 2006

    Report

    Report Number
    1222315-2006-00009
    Event Type
    Other
    Date Received
    November 17, 2006
    Report Date
    November 17, 2006
    Manufacturer
    BIORA AB
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER COMPLETED AN ANALYSIS OF THE PRODUCT DHR AND HAS DETERMINED THAT IT HAS MET IT'S SPECIFICATIONS.

    Description of Event or Problem · 1

    ON 10/20/06 THE SALES REPRESENTATIVE CALLED IN TO CUSTOMER SERVICE REPRESENTATIVE STATING THAT THE CLINICIAN WHO HAS TREATED SOME OF HIS PATIENTS WITH BONE CERAMIC HAVE HAD INFECTIONS. SALES REPRESENTATIVE STATED CLINICIAN HAD FIVE PATIENTS THAT HAVE HAD PROBLEMS WITH BONE CERAMIC. ON 11/10/2006 A REGULATORY AFFAIRS REPRESENTATIVE SPOKE WITH THE CLINICIAN'S OFFICE PERSONNEL TO ASK THE CLINICIAN TO COMPLETE A QUESTIONNAIRE SBC, PATIENT CASE DOCUMENTATION. DURING THAT CONVERSATION, THE CLINICIAN STATED THAT THE NUMBER OF PATIENTS INVOLVED IS NOT SEVEN. THE COMPLAINT STATES THAT THERE IS A HOLE IN THE MEMBRANES AND SOFT TISSUE. THE SPECIFIC PATIENTS HAVE NOT YET BEEN IDENTIFIED TO STRAUMANN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAUMANN BONE CERAMIC SYNTHETIC BIPHASIC CALCIUM PHOSPHATE LYC BIORA AB 070.203 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other