BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, REPLACEMENT

    MDR report key: 6827175 · Received August 29, 2017

    Report

    Report Number
    0001038806-2017-00571
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    July 24, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): ADDITIONAL 510K CODES: K002188.

    Additional Manufacturer Narrative · 1

    ONE ZIMMER UNIVERSAL RETAINING SCREW WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE SCREW WAS FRACTURED AT THE THREADED REGION. THE ALLEGED COMPLAINT IS THEREFORE CONFIRMED. 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. A SINGULAR CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETAINING SCREW FRACTURED. THE FRACTURED TIP OF RETAINING SCREW WAS REMOVED, THEN ANOTHER PRODUCT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609212 SCREW, REPLACEMENT ABUTMENT SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR