BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 6656002 · Received June 20, 2017

    Report

    Report Number
    0001038806-2017-00339
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    April 4, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZIMMER HEX-LOCK ABUTMENT WAS RETURNED FOR INSPECTION WITH RETAINING SCREW. THE DEVICE SHOW SIGNS OF WEAR AT THE HEX SURFACE AND COLLAR. THIS SCREW WAS CONFIRMED TO BE FRACTURED AT THE THREADED REGION. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS 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: ¿INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS¿ 4894I REV 3-07/09. INFORMATION IDENTIFIED: ¿ABUTMENTS FOR CEMENT-RETAINED PROSTHESIS - HEX-LOCK FIXED ABUTMENT TO INITIATE FINAL SEATING OF THE ABUTMENT OR ABUTMENT SCREW, USE THE HEX DRIVE SEATING TOOL. TO ACHIEVE OPTIMUM TORQUE, USE OF A PROSTHETIC TORQUE WRENCH IS RECOMMENDED. BEFORE CEMENTING THE FINAL PROSTHESIS IN PLACE, VERIFY OCCLUSION IN CENTRIC AND LATERAL EXCURSIONS.¿ THE COMPLAINT WAS CONFIRMED FOLLOWING INSPECTION. THE ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿.

    Additional Manufacturer Narrative · 1

    PMA 510(K): K013227/K953101.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS AN ABUTMENT/ABUTMENT SCREW (HLA4-5) PLACED (B)(6)2013 FRACTURED WITHIN AN UNKNOWN IMPLANT ON (B)(6) 2017. THE CLINICIAN WAS UNABLE TO RETRIEVE THE LOWER FRACTURED PORTION OF THE SCREW FROM THE IMPLANT, THEREFORE THE UNKNOWN IMPLANT WAS REMOVED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434101 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE IMPLANT ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention