BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE INC.

    MDR report key: 7470914 · Received April 27, 2018

    Report

    Report Number
    3008272529-2018-00016
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 13, 2018
    Report Date
    April 17, 2018
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DID NOT SHOW ANY MALFUNCTION. THE COMPLICATION MAY BE CAUSED BY GUIDE NOT POSITIONED PROPERLY IN THE PATIENT'S MOUTH AND/OR NOT FOLLOWING TISSUE FLAP REQUIREMENT PRIOR TO GUIDE SEATING.

    Description of Event or Problem · 1

    DOCTOR USED A SURGICAL GUIDE TO PLACE DENTAL IMPLANT. HE PERFORMED OSTEOTOMY FOR 26 AND 28 AND PROBED THE SITE BEFORE PLACING IMPLANT. HE NOTICED THERE WAS NO LINGUAL WALL FOR 26. DOCTOR THEN TOOK A CBCT SCAN OF PATIENT TO SEE SITE 26 AND 28 WHICH SHOWED IMPLANT 28 PIERCED LINGUAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310816 ANATOMAGE INC. SURGICAL GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention