BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED 4.5 - 11 MM

    MDR report key: 24688298 · Received March 25, 2026

    Report

    Report Number
    3013111692-2026-09900
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 25, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN IMPLANT LOSS. SF- (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747512 OSSEOSPEED 4.5 - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 62142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NOT PROVIDED