BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE TAPERED GROOVY RP 4.3X8MM

    MDR report key: 9185521 · Received October 14, 2019

    Report

    Report Number
    2027971-2019-25121
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    June 28, 2019
    Report Date
    July 9, 2019
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    UDI-DI
    07332747001839
    PMA / PMN Number
    K050258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVOKED ASR EXEMPTION NUMBER E1997036. 'REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION'. THIS REPORT IS RE-SUBMITTED DUE TO WEBTRADER INDICATION OF A FAILED ORIGINAL SUBMISSION AND REFUSAL TO ACCEPT SUBMISSION WITH THE SAME MDR ID NUMBER. A DUPLICATE REPORT MAY EXIST WITH REPORT NUMBER 2027971-2019-17554. THIS REPORT SHALL SUPERSEDE REPORT NUMBER 2027971-2019-17554 IF DUPLICATION IS IDENTIFIED IN THE ADVERSE EVENT REPORTING DATABASE.

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979302 NOBELREPLACE TAPERED GROOVY RP 4.3X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA, LLC 32215 13034820 07332747001839

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention