BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TITANIUM ABUTMENT

    MDR report key: 5832099 · Received July 28, 2016

    Report

    Report Number
    0002031503-2016-00051
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Report Date
    June 29, 2016
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFORMATION WILL BE AVAILABLE UPON EVALUATION OF THE RETURNED PART. THE EVALUATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DENTAL LABORATORY THAT A VARIETY OF ABUTMENTS THAT THEY USED HAD UNBONDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016 BY LABORATORY PERSONNEL. HE REPORTED THAT HE WAS HAVING ISSUE WITH THE TITANIUM ABUTMENT BONDING TO ZIRCONIA MILLING CROWNS. FURTHER DESCRIBED AS" THE CEMENT TO THE T-BASE TO ZIRCONIA WOULD SEPARATE". HE STATED THAT THIS HAD OCCURED IN THE LAB SETTING A FEW TIMES( NOT EXACTLY SURE HOW MANY) NO CONTACT WITH THE PATIENT. LABORATORY REQUESTED INFORMATION ON TYPE OF CEMENT TO USE. ADDITIONAL INFORMATION ON (B)(6) 2016: LABORATORY WAS AWARE OF AN ABUTMENT THAT DEBONDED IN THE MOUTH OF A PATIENT. IT WAS IN SERVICE FOR ONE YEAR, WHEN HE WAS INFORMED THAT IT WAS LOOSE AND DEBONDED IN THE PATIENT'S MOUTH. LABORATORY PERSONNEL STATED THAT THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT NOR INJURY AS FAR AS HE KNEW AND REMEMBERED. HE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT NOR COLLECTION OF THE DOCTOR THAT REPORTED IT. HE STATED THAT THERE WAS NO ISSUE WITH THE ABUTMENTS THEMSELVES, HOWEVER; THE ISSUE WAS WITH THEM BONDING TO THE CEMENT ( IVOCLAR MULTI-LINK CEMENT). THEREFORE, HE SENT THE UNUSED INVENTORY BACK. LAB REPORTED THEY PURCHASED A DIFFERENT BRAND OF CEMENT ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482277 INCLUSIVE TITANIUM ABUTMENT DENTAL ABUTMENT NHA PRISMATIK DENTALCRAFT, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1