BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 6836581 · Received August 31, 2017

    Report

    Report Number
    0001038806-2017-00582
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    June 29, 2016
    Report Date
    August 31, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ABUT GOLD FRICTION-FIT 3. 5MM IMP (HLA3G) WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED SIGNS OF GENERAL USAGE WERE NOTED ON THE VISIBLE PORTION OF THE RETURNED ABUTMENT. HOWEVER, THERE WAS NO DAMAGED THAT COULD PREVENT THE PRODUCT FROM FUNCTIONING AS INTENDED WERE IDENTIFIED. 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: 4894I REV 3-07/09 - INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS CONTAINS INSTRUCTIONS AND ABUTMENT PLACEMENT RECOMMENDATIONS. 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. NOTE: SOME HEX OR OCTAGON PROSTHETIC COMPONENTS ARE DESIGNED FOR USE IN MULTIPLE UNIT CASES AND MAY BYPASS THE INTERNAL HEX/OCTAGON. EXTERNAL HEX - TO PROPERLY SEAT EXTERNAL HEX PROSTHETIC COMPONENTS, IT IS REQUIRED THAT THE COMPONENTS ACCURATELY FIT OVER THE RAISED HEXAGON ON THE CORONAL PORTION OF THE IMPLANT BODY. PROSTHETIC COMPONENTS WITH AN INTERNAL HEXAGON MUST BE PROPERLY INDEXED OVER THE RAISED HEXAGON PRIOR TO PROCEEDING WITH THE RESTORATIVE PHASE. TO ENSURE FIRM AND COMPLETE SEATING, APPLY MAXIMUM TORQUE FROM THE THUMB AND FOREFINGER TO THE SEATING TOOL THEN USE THE PROSTHETIC TORQUE WRENCH. PROSTHETIC TORQUE WRENCH TO ENSURE THAT CONSISTENT TORQUE IS APPLIED TO ALL ABUTMENTS, RETAINING AND COPING SCREWS, A PROSTHETIC TORQUE WRENCH MUST BE USED. AS THE EXACT CONDITIONS OF USAGE OF UNKNOWN, THE REPORTED EVENT COULD NOT BE VERIFIED. A TECHNICAL ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL 510K NUMBERS- K013227, K953101.

    Description of Event or Problem · 1

    THE DOCTOR INDICATES THE ABUTMENT SCREW (HLA3G) BECAME LOOSE. THE DOCTOR CHANGED THE ABUTMENT AND NEW CROWN HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614135 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR