BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, REPLACEMENT

    MDR report key: 6703553 · Received July 11, 2017

    Report

    Report Number
    0001038806-2017-00407
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 19, 2017
    Report Date
    September 26, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK953101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MHLAS ZIMMER RETAINING SCREW WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED SIGNS OF WEAR DUE TO USAGE AROUND THE THREADS AND THE SHANK. THERE WAS NOTICEABLE GOUGING AROUND THE HEX CIRCUMFERENCE AND WEAR AROUND THE COLLAR. 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: 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. THE COMPLAINT WAS NON-VERIFIABLE, AS THE EXACT DETAILS OF THE DEVICE USAGE WERE UNKNOWN AND THE REPORTED LOOSENING COULD NOT BE REPLICATED. THE CONDITIONS UNDER WHICH THE IMPLANT WAS SUBJECTED IN THE PATIENT¿S MOUTH ARE UNKNOWN. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THE ABUTMENT SCREW PROVIDED FROM LAB WITH UNKNOWN ABUTMENT IS LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484031 SCREW, REPLACEMENT ABUTMENT SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1