BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TE Ø 4.8MM WN, SLA® 10MM, TIZR, NTP

    MDR report key: 15086676 · Received July 22, 2022

    Report

    Report Number
    0001222315-2022-15588
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 22, 2022
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031719263
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 31. ON (B)96) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106359 TE Ø 4.8MM WN, SLA® 10MM, TIZR, NTP ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA Roxolid TL ZC193 07630031719263

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention