BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE

    MDR report key: 7101810 · Received December 8, 2017

    Report

    Report Number
    0001038806-2017-00890
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    October 24, 2017
    Report Date
    January 18, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HEX-LOCK ABUTMENT (HLA3/5) WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED SIGNS OF WEAR DUE TO USAGE AROUND THE HEX AND THE COLLAR. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT NUMBER. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS (4894I REV. 3 - 07/09). 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. A SINGULAR CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K NUMBERS: K013227 AND K953101

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT LOOSENED. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881056 ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE ABUTMENT DZE ZIMMER DENTAL 63260194

    Patients

    Seq Age Sex Outcome Treatment
    1