BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACE SELECT TAPERED TIU RP 4.3X13MM

    MDR report key: 657895 · Received December 21, 2005

    Report

    Report Number
    2027763-2005-11646
    Event Type
    Injury
    Date Received
    December 21, 2005
    Date of Event
    August 23, 2005
    Report Date
    September 23, 2005
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2005 - A DENTAL IMPLANT WAS PLACED IN TOOTH LOCATION # 28. SUBSEQUENTLY THE PT WAS EXPERIENCING PARESTHESIA. ABOUT THREE WEEKS LATER - THE IMPLANT WAS REMOVED FROM PT'S MOUTH. THREE MONTHS LATER - THE CLINICIAN WAS CONTACTED. SHE STATED THE PT DEVELOPED POST-OPERATIVE PARESTHESIA. AFTERWARDS THE IMPLANT WAS REMOVED FROM THE PT'S MOUTH AND THE PARESTHESIA DISSOLVED. THE PT WAS SEEN POST-OPERATIVE AND IS DOING WELL WITH NO PROBLEM. THE PT HAS SINCE BEEN RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACE SELECT TAPERED TIU RP 4.3X13MM DZE DZG NOBEL BIOCARE AB * 654864

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization