BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    NOBELREPLACE CC RP 5.0X10MM

    MDR report key: 8846660 · Received July 31, 2019

    Report

    Report Number
    2027971-2019-00025
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    July 31, 2019
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    UDI-DI
    07332747035667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: 1997036; INTERNAL REFERENCE NUMBER: (B)(4). THE INVESTIGATION OF THE ADVERSE EVENTS SUMMARIZED IN THIS REPORT (N=10,146) DID NOT CONCLUDE ANY UNACCEPTABLE PRODUCT PROBLEM WITH THE AFFECTED DEVICES. THE EVENTS SUMMARIZED ARE KNOWN INHERENT RISKS OF THE DEVICE, WHICH ARE IDENTIFIED IN THE RISK ASSESSMENT AND ARE INCLUDED IN THE INSTRUCTIONS FOR USE. TRENDING ANALYSIS PERFORMED FOR EACH OF THE EVENT CONFIRMED THAT THE FAILURE RATES ARE IN ACCORDANCE WITH ACCEPTANCE CRITERIA BASED ON SCIENTIFIC LITERATURE. NO REMEDIAL ACTION WAS THEREFORE NECESSARY.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 10,146 <NOE> REPORTED EVENTS. IT INCLUDES KNOWN EVENTS SUCH AS FAILURE TO OSSEOINTEGRATE, LOSS OF OSSEOINTEGRATION AND LATE FRACTURES OF AN ENDOSSEOUS DENTAL IMPLANT. THE AGE RANGE OF THE INCIDENT EVENTS IS: 17 TO 97 YEARS. (AVERAGE: 59 YEARS). THE GENDER BREAKDOWN IS 5062 MALE, 4602 FEMALE AND 482 UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641795 NOBELREPLACE CC RP 5.0X10MM ENDOSSEOUS DENTAL IMPLANT. DZE NOBEL BIOCARE USA, LLC 36711 13062967 07332747035667

    Patients

    Seq Age Sex Outcome Treatment
    1