BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ZIRCONIA ABUTMENT

    MDR report key: 3900588 · Received June 27, 2014

    Report

    Report Number
    0001038806-2014-00053
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK052648
    Removal / Correction Number
    Z-1215-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THIS EVENT IS BEING REPORTED DUE TO A SINGLE PRECEDING MEDICAL DEVICE REPORT WHERE SURGICAL INTERVENTION DID OCCUR. THIS EVENT IS A SUBSEQUENT MALFUNCTION. THE RISK TO THE PATIENT IS REMOTE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: REVIEWED 3SHAPE AND INSPECTED THE ABUTMENT. THE ABUTMENT WAS INSPECTED UNDER THE MICROSCOPE AND DOES NOT APPEAR TO BE FRACTURED. HOWEVER, REVIEW OF THE ABUTMENT SHOWS THAT IT WAS SLIGHTLY MODIFIED ON THE TOP OF THE ABUTMENT. THE ABUTMENT WAS DESIGNED PER THE WORK ORDER WITH THE EXCEPTION OF THE OCCLUSAL CLEARANCE. THE CUSTOMER ASKED FOR 2.5MM AND IT WAS DESIGNED AT 1.6MM DUE TO THE HEIGHT OF THE ABUTMENT BEING AT THE MINIMUM DESIGN OF (B)(4). THIS IS THE REASON WHY THE ABUTMENT IS SHORT DUE TO THE OCCLUSAL CLEARANCE REQUESTED.

    Description of Event or Problem · 1

    THE DENTIST INDICATED THAT THE ZIRCONIA ABUTMENT PLACED ON (B)(6) 2013 FRACTURED ON (B)(6) 2014. THE ABUTMENT WAS INCORRECTLY SIZED (SHORT) FOR THE TYPE AND SIZE OF TOOTH TO BE REPLACED FOR PATIENT'S COMPROMISED BITE. THE CROWN DISLODGED FROM THE ABUTMENT. THE DENTIST REPORTED THAT THERE WAS NO SERIOUS PATIENT INJURY, NO DETERIORATION IN PATIENT¿S HEALTH AND NO CONTRIBUTING CONDITIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377353 BELLATEK® ZIRCONIA ABUTMENT BELLATEK® ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1160936

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR