BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    NOBELACTIVE INTERNAL RP 4.3X13MM

    MDR report key: 8024183 · Received October 31, 2018

    Report

    Report Number
    2027971-2018-00008
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    UDI-DI
    07332747010640
    PMA / PMN Number
    K050858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: 1997036. TOTAL NUMBER OF EVENTS BEING SUMMARIZED: 17,176. INTERNAL REFERENCE NUMBER FOR THE REPRESENTATIVE REPORT: (B)(4). THE INVESTIGATION OF THE ADVERSE EVENTS SUMMARIZED IN THIS REPORT DID NOT CONCLUDE ANY 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 EVENTS CONFIRMED THAT THE FAILURE RATES ARE BELOW THE ACCEPTANCE CRITERIA BASED ON SCIENTIFIC LITERATURE. NO REMEDIAL ACTION WAS THEREFORE NECESSARY [ASR Q3 2018].

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 17,176 </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 INCLUDED EVENTS IS: 16 TO 99 YEARS (AVERAGE: 59 YEARS). THE GENDER BREAKDOWN IS: 8,640 MALE, 7,902 FEMALE AND 634 UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866535 NOBELACTIVE INTERNAL RP 4.3X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA, LLC 34133 13052854 07332747010640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention