BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA ESTH CON ZI ABUT SD 4.0X2MM

    MDR report key: 2190942 · Received July 19, 2011

    Report

    Report Number
    3005990499-2011-00032
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    March 20, 2010
    Report Date
    June 21, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K072572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETELY DETACHED INTERNAL LOBE SECTION OF THE ABUTMENT, THE ABUTMENT BODY AND THE ABUTMENT SCREW WERE RETURNED FOR EVAL. THE AREA OF BREAKAGE FROM THE CUFF PORTION OF THE ABUTMENT WAS FOUND TO BE RAGGED AND UNEVEN AND COMPLETELY DETACHED FROM THE ABUTMENT; THE INTERNAL LOBES SECTION OF THE ABUTMENT WAS ALSO COMPLETELY DETACHED FROM THE ABUTMENT AND CUFF. FRACTURES AROUND THE BASE OF THE ZIRCONIUM ABUTMENT ARE TYPICALLY CAUSED BY A TORQUE SETTING OVER THE RECOMMENDED 30 NCM AND/OR MISALIGNMENT DURING PLACEMENT; HOWEVER, THE ROOT CAUSE OF THIS FAILURE COULD NOT BE CONFIRMED. THIS PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE, CONSEQUENTLY, THERE IS NO EXPIRATION DATE. ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO. A F/U MEDWATCH FORM WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED AT A LATER DATE. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A PT HAD A PRIMA ZI ABUTMENT PLACED AT AN (B)(4) DENTAL SITE NUMBER 31 ON (B)(6), 2010. THE ABUTMENT WAS REPORTED TO HAVE FRACTURED (B)(6), 2011. THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE EFFECT TO THE PT 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 SD 4.0X2MM NHA KEYSTONE DENTAL 45081K MM03643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK