BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 7388317 · Received April 2, 2018

    Report

    Report Number
    0001038806-2018-00342
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Report Date
    July 16, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ZIMMER FRICTION FIT ABUTMENT RESTORATION WAS RETURNED FOR INSPECTION WITH A RESTORATION SCREW. THE SCREW SHOWS SIGNS OF WEAR FROM USE ABOUT THE THREADS AND HEAD. ITS INTERNAL DRIVE FEATURE IS HEAVILY WORN FROM USE, BUT REMAINED FUNCTIONAL. THE ABUTMENT HEX IS ALSO WORN AND CONTAINS DEBRIS ALONG THE HEX FEATURE. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: 'INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS' 4894I REV 3-07/09. INFORMATION IDENTIFIED: SEATING OF PROSTHETIC COMPONENTS INTERNAL HEX OR OCTAGON COMPONENTS - TO PROPERLY SEAT THESE PROSTHETIC COMPONENTS, PLACE THE ABUTMENT RETAINING SCREW THROUGH THE ABUTMENT AND PLACE THE ASSEMBLY INTO THE INTERNAL BEVEL AT THE CORONAL PORTION OF THE IMPLANT. ROTATE IT UNTIL THE ABUTMENT DROPS INTO PLACE. THE MALE HEX OR OCTAGON SHOULD SEAT FULLY IN THE FEMALE HEX OR OCTAGON OF THE IMPLANT ONCE THE TORQUE WRENCH HAS BEEN USED TO TIGHTEN THE ABUTMENT TO 30NCM. COMPLAINT INDICATES CONTINUOUS LOOSENING OF THE RESTORATION OVER AN EXTENSIVE PERIOD OF TIME. THE ALLEGED EVENT WAS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. THE ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF THIS REPORT. CONTACT OFFICE - NAME/ADDRESS. FOLLOW-UP NUMBER. FOLLOW UP TYPE. DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO" TO "YES". EVALUATION CODES. ADDITIONAL NARRATIVE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER K013227 / K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HLA3G ABUTMENT LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231784 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1