BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5

    MDR report key: 1860126 · Received September 21, 2010

    Report

    Report Number
    3005990499-2010-00017
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 1, 2010
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FRACTURED ABUTMENT WAS RETURNED ATTACHED TO THE CROWN. MICROSCOPIC EVAL REVEALED EVIDENCE OF MODIFICATION TO THE WALL THICKNESS. DUE TO THE INHERENT NATURE OF THE MATERIAL, FAILURES OF THIS TYPE ARE NOT UNEXPECTED. THE ROOT CAUSE CAN BE ATTRIBUTED TO USER TECHNIQUE AND/OR OPERATIONAL CONTEXT. ALSO, FRACTURE CAN OCCUR AT THE BASE OF THE ZIRCONIUM ABUTMENT IF A TORQUE SETTING OVER THE RECOMMENDED 30 NCM IS APPLIED. PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE PART, CONSEQUENTLY, THERE IS NO EXP DATE (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THE ZIRCONIUM ABUTMENT FRACTURED, THE ABUTMENT AND CROWN WERE REPLACED. THE ABUTMENT WAS PLACED AT (B)(6), 2010, THE ABUTMENT FRACTURED (B)(6), 2010. THE COMPLAINT REPORT DID NOT INDICATE ANY PT ADVERSE EFFECT AS A RESULT OF THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA ESTH CON ZI ABUT RD 5.0X1.5 NHA KEYSTONE DENTAL 45083K MM01213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK