BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 6 .5 FLARE

    MDR report key: 7125130 · Received December 18, 2017

    Report

    Report Number
    0001038806-2017-00920
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 10, 2017
    Report Date
    January 31, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K013227/K953101. INITIAL REPORTER: TITLE, EMAIL ADDRESS, AND STATE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    ONE TAPERED SCREW VENT IMPLANT WAS RETURNED FOR INSPECTION WITH A REMOVED RESTORATION CONTAINING A HEX-LOCK ABUTMENT. THE IMPLANT SHOWS LARGE SIGNS OF WEAR ABOUT THE THREADS, COLLAR, AND INTERNAL DRIVE FEATURE. THE INTERNAL DRIVE FEATURE IS CONFIRMED TO CONTAIN THE REPORTED FRACTURED SCREW, WHICH WAS TOO BADLY DAMAGED TO BE REMOVED. THE COLLAR IS ALSO FRACTURED. THE ABUTMENT IS LIKEWISE CONFIRMED TO BE FRACTURED AT THE HEX FEATURE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. 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. THE RETURNED X-RAY SHOWS THE REPORTED IMPLANT IN THE SURGICAL SITE. THIS IMAGE CONFIRMS THAT THE IMPLANT IS CONFIRMED TO BE FRACTURED ABOUT THE COLLAR. COMPLAINT INDICATES FRACTURING OF THE ABUTMENT, WHICH LED TO FRACTURE OF THE ABUTMENT SCREW AND IMPLANT. ALL COMPONENTS REQUIRED REMOVAL. THE ALLEGED EVENT WAS CONFIRMED FOLLOWING INSPECTION. A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE ENGAGING PART OF THE HEX-LOCK ABUTMENT FRACTURED AND LED TO THE FRACTURE OF THE IMPLANT PLATFORM. CONSEQUENTLY, THE IMPLANT HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904155 ABUT HEX-LOCK 4.5MM IMP 6 .5 FLARE ABUTMENT DZE ZIMMER DENTAL 62832835

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention