BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø2.9MM SC, SLACTIVE® 12MM, RXD, LOXI

    MDR report key: 9498760 · Received December 19, 2019

    Report

    Report Number
    0001222315-2019-14480
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 25, 2019
    Report Date
    December 19, 2019
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031728012
    PMA / PMN Number
    K162890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)96) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2019, NON-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
    1288926 BLT Ø2.9MM SC, SLACTIVE® 12MM, RXD, LOXI ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG TR472 07630031728012

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention