BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDCEM PLUS

    MDR report key: 7429052 · Received April 13, 2018

    Report

    Report Number
    9612352-2018-00001
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    February 9, 2018
    Report Date
    April 11, 2018
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EMA
    PMA / PMN Number
    K091019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT AFTER USING SPEEDCEM PLUS TO CEMENT CROWNS, 5 PATIENTS EXPERIENCED BITE DISCOMFORT AND PULPITIS WITH PAIN. OF THOSE 5 PATIENTS 2 HAD TO UNDERGO ENDODONTIC TREATMENT. THE RELEVANT BATCH (681712WW) MET ALL THE SPECIFICATIONS AND QUALITY CRITERIA FOR RELEASE. THE INFORMATION PROVIDED SHOWED TWO POTENTIAL APPLICATION ERRORS BY THE DENTIST, WHICH MIGHT HAVE CONTRIBUTED TO THE POSTOPERATIVE SENSITIVITIES: THE ZIRCONIUM OXIDE CROWNS WERE ETCHED BEFORE INSERTION, WHICH IS NOT INDICATED. THE PREPARATION OF THE ABUTMENT TEETH WAS NOT RETENTIVE. DOCTOR DID NOT RETURN SPEEDCEM PLUS MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271009 SPEEDCEM PLUS CEMENT, DENTAL EMA IVOCLAR VIVADENT AG W34777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other