BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTCEM 2 SELF-ADHESIVE RESIN CEMENT

    MDR report key: 3802846 · Received May 2, 2014

    Report

    Report Number
    2515379-2014-00021
    Event Type
    Injury
    Date Received
    May 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EMA
    PMA / PMN Number
    K073173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVALUATION OF THE DEVICE INVOLVED IS NOT POSSIBLE AND SINCE THIS ISSUE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS INITIALLY REPORTED THAT SEVERAL CROWNS DEBONDED AFTER CEMENTATION WITH SMARTCEM2. AT THE TIME OF THE INITIAL REPORT, THERE WERE NO INJURIES AND THE CROWNS ONLY REQUIRED RE-CEMENTATION (AN ACTION NOT CONSIDERED AS MEDICAL INTERVENTION). HOWEVER, ON (B)(6) 2014 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ONE PATIENT WILL NEED TO UNDERGO AN ADDITIONAL DENTAL PROCEDURE AS A RESULT OF THE CEMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264001 SMARTCEM 2 SELF-ADHESIVE RESIN CEMENT DENTAL CEMENT EMA DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention