BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ZIRCONIA ABUTMENT

    MDR report key: 3848940 · Received June 4, 2014

    Report

    Report Number
    0001038806-2014-00042
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 6, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RETURNED, HOWEVER THE INVESTIGATION HAS NOT YET BEEN CONCLUDED. 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

    THE ABUTMENT FRACTURED AT THE HEX AND ON THE MESIAL SIDE. THE DHR AND 3SHAPE REVIEW SHOWS THE DESIGN TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED BY THE CUSTOMER, NO SPECIFIC ROOT CAUSE CAN BE DETERMINED. PER PRODUCT HISTORY REVIEW, WHEN FRACTURE OF AN ENCODE ZIRCONIA ABUTMENT IS OBSERVED AT OR ADJACENT TO THE MATING HEX OR BOSS, THE ROOT CAUSE OF THE FRACTURE IS RELATED TO THE DESIGN OF THE HEX AND BOSS CONNECTION FEATURES, AND THE SCREW ACCESS HOLE AS DOCUMENTED IN CORRECTIVE ACTION (B)(4). REFER TO CAPA-(B)(4) AND ATTACHED MEMO FOR DETAILS. CHANGED EVALUATION METHOD CODE TO - OTHER (CODE UNSPECIFIED). CORRECTION NUMBER - UPDATED FDA CORRECTION/REMOVAL REPORTING NUMBER.

    Description of Event or Problem · 1

    ON (B)(60 )2014, THE PATIENT REPORTED TO HIS DENTIST THAT THE ABUTMENT THAT WAS RESTORED ON (B)(6) 2012 HAD FRACTURED. 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
    327202 BELLATEK® ZIRCONIA ABUTMENT BELLATEK® ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1094730

    Patients

    Seq Age Sex Outcome Treatment
    1