BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5

    MDR report key: 1860142 · Received September 21, 2010

    Report

    Report Number
    3005990499-2010-00019
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 23, 2010
    Report Date
    September 8, 2010
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZIRCONIUM ABUTMENT AND SCREW WERE RETURNED FOR EVAL. VISUAL INSPECTION REVEALED THE BASE OF THE ABUTMENT WAS FRACTURED. MICROSCOPIC EVAL REVEALED THE FRACTURE ORIGINATED AROUND THE NECK OF THE INTERNAL LOBE CONNECTION. 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, FRACTURES CAN OCCUR AT THE BASE OF THE ZIRCONIUM ABUTMENT IF A TORQUE SETTING OVER THE RECOMMENDED 30 NCM IS APPLIED. FURTHERMORE, MISALIGNED INTERNAL LOBES AT THE CONNECTION DURING PLACEMENT IS ANOTHER POTENTIAL CAUSE OF ZIRCONIUM ABUTMENT FRACTURES. VISUAL ANALYSIS ALSO REVEALED THAT THE ABUTMENT WAS PREPPED AND WAS FITTED TO THE CROWN. ANOTHER FRACTURE WAS LOCATED AT THE HEAD OF THE ABUTMENT'S RETAINING SCREW JUST BELOW THE AREA WHERE THE CROWN WAS POSITIONED. THIS FRACTURE SURFACE IS RELATIVELY FLAT AND CIRCUMFERENTIAL. IT APPEARS TO BE IN A PLANE AT AND ADJACENT TO THE LEVEL OF THE IMPLANT INTERFACE. THIS IS A LOCATION THAT IS WELL KNOWN TO BE A STRESS RISER. IT IS PRESUMED THAT THE ABUTMENT WAS "PREPPED" TO ALLOW THE CROWN TO FIT, AS THE WALL THICKNESS OF THE ABUTMENT WAS FOUND TO BE SIGNIFICANTLY REDUCED. THE PREPPING PERFORMED TO FIT THE CROWN IS THE LIKELY CAUSE OF THIS PORTION OF THE PREMATURE ABUTMENT FRACTURE. 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 A PRIMA ZIRCONIUM ABUTMENT PLACED AT FDI SITE # 12 IN A MALE PT ON (B)(6), 2010. THE ABUTMENT WAS REPORTED TO HAVE FRACTURED DURING NORMAL FUNCTION ON (B)(6), 2010. THE COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE AFFECT TO THE PT AS A RESULT OF THE REPORTED PROBLEM. BOTH THE ABUTMENT AND ABUTMENT SCREW WERE REMOVED WITHOUT DIFFICULTY OR THE NEED FOR AUXILIARY TOOLS. THE IMPLANT REMAINED IN THE PT AND FUNCTIONAL.

    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 MM00293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK