BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBRPL TAPERED GROOVY NP 3.5X11.5MM

    MDR report key: 12774192 · Received November 8, 2021

    Report

    Report Number
    2027971-2021-127733
    Event Type
    Death
    Date Received
    November 8, 2021
    Report Date
    November 8, 2021
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM. THE PRESENT SUBMISSION/SUBMISSIONS IS/ARE CORRECTIVE SUBMISSION/SUBMISSIONS FOR THE INCORRECT MFG. SUBMISSION/SUBMISSIONS RELATED TO (B)(4). THE CORRECTIVE ACTION HAS BEEN TAKEN UNDER FDA CDRH EMDR [email protected] GUIDANCE. DEATH WAS SELECTED IN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669613 NOBRPL TAPERED GROOVY NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| D