BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELSPEEDY GROOVY RP 4X10MM

    MDR report key: 16846920 · Received May 1, 2023

    Report

    Report Number
    2027971-2023-070252
    Event Type
    Death
    Date Received
    May 1, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 1, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747159820
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INITIAL REPORT DID NOT HAVE THE CORRECT OUTCOMES ATTRIBUTED TO ADVERSE EVENT - DEATH, THE CORRECT ONE - REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)IS PROVIDED IN THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    THE IMPLANT MALFUNCTIONED DUE TO IT DEFORMING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782541 NOBELSPEEDY GROOVY RP 4X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 32148 12139836 07332747159820

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death| R