BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA ESTH CON ZI ABUT 15 DEGREE SD 4.0

    MDR report key: 1931203 · Received November 11, 2010

    Report

    Report Number
    3005990499-2010-00028
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    January 26, 2010
    Report Date
    October 14, 2010
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED; THEREFORE, A FULL INVESTIGATION INTO THE ROOT CAUSE OF THE DEVICE FAILURE COULD NOT BE PERFORMED. POSSIBLE CAUSES OF FRACTURE OF A ZIRCONIA ABUTMENT INCLUDE A TORQUE SETTING OVER THE RECOMMENDED 30NCM, MISALIGNMENT OF THE ABUTMENT DURING PLACEMENT, AND/OR MODIFICATION OF THE ABUTMENT DURING PREP. PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON STERILE PART, CONSEQUENTLY, THERE IS NO EXPIRATION DATE. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A MALE PT HAD A PRIMA ZI ABUTMENT PLACED AT (B)(6) ON (B)(6), 2009. THE ABUTMENT WAS REPORTED TO HAVE FRACTURED ON (B)(6), 2010. THE COMPLAINANT REPORTED THAT THE DEVICE WILL NOT BE REC'D AS THE PT SWALLOWED THE ABUTMENT. THERE WERE NO INDICATIONS OF ANY ADVERSE EFFECTS TO THE PT AS A RESULT OF THE SWALLOWED ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA ESTH CON ZI ABUT 15 DEGREE SD 4.0 NHA KEYSTONE DENTAL 45082K MM00337

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK