BEUDAMED
    FDA Adverse Event Summary report: N

    IPS EMPRESS CAD

    MDR report key: 5765807 · Received July 1, 2016

    Report

    Report Number
    9612352-2016-00002
    Date Received
    July 1, 2016
    Date of Event
    June 1, 2016
    Report Date
    July 1, 2016
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EIH
    PMA / PMN Number
    K980986
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INGESTION OF FOREIGN OBJECTS CAN OCCUR AT ANY TIME DURING DENTAL PROCEDURES. ONCE A FOREIGN OBJECT HAS REACHED THE STOMACH IT IS EXPECTED THAT IT WILL PASS THROUGH THE GASTROINTESTINAL TRACT AS A RESULT OF PERISTALSIS MOVEMENT WITHOUT COMPLICATION, USUALLY AFTER A 7-10 DAY PERIOD. FOLLOW UP WITH PATIENT ON (B)(6) 2016 INDICATED IMPROVEMENT AND PILL CAMERA PROCEDURE REVEALED EVIDENCE OF HEALING. PATIENT REPORTS CT SCANS, COLONOSCOPY AND ENDOSCOPY PROCEDURES CONDUCTED WITH NO EVIDENCE OF BROKEN TOOTH PIECE FOUND.

    Description of Event or Problem · 1

    PATIENT SWALLOWED PORTION OF IPS EMPRESS CAD CROWN THAT HAD BEEN PLACED ON TOOTH #18 BY THE DENTIST ON (B)(6) 2013. PATIENT RETURNED TO DENTIST ON (B)(6) 2016 INDICATING THAT A PIECE OF THE CROWN WAS SWALLOWED AFTER EATING ALMONDS. THE DOCTOR CONFIRMED THAT A PORTION OF THE PATIENTS CROWN FRACTURED ON THE DISTOLINGUAL CUSP. ON (B)(6) 2016 THE PATIENT RETURNED TO THE OFFICE CLAIMING THE PORTION OF THE CROWN SWALLOWED CAUSED PAIN AND DAMAGE TO HIS DIGESTIVE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419372 IPS EMPRESS CAD PORCELAIN/POWDER EIH IVOCLAR VIVADENT AG

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention