BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5

    MDR report key: 1970264 · Received January 14, 2011

    Report

    Report Number
    3005990499-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 29, 2010
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER OF THE ABUTMENT AT ISSUE IN THIS COMPLAINT; CONSEQUENTLY, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THE CLINICIAN INDICATED THAT THE DEVICE HAD BEEN INADVERTENTLY DISCARDED AT THE COMPLAINANT FACILITY; THEREFORE, THE PRODUCT WAS NOT RETURNED. AS A RESULT, A FULL INVESTIGATION INTO THE ROOT CAUSE OF THE DEVICE FAILURE COULD NOT BE PERFORMED. POSSIBLE CAUSES OF A ZIRCONIA ABUTMENT FRACTURE 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 NOTED. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A FEMALE PATIENT HAD A PRIMA ZI ABUTMENT PLACED AT FDI SITE NUMBER 13 ON (B)(6) 2008. THE ABUTMENT WAS REPORTED TO HAVE FRACTURED DURING NORMAL FUNCTION ON (B)(6) 2010, AND BECAME LODGED IN THE IMPLANT. THE CLINICIAN SUCCESSFULLY REMOVED THE ABUTMENT WITH THE AID OF A DIAMOND BURR. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ABUTMENT FRACTURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention