BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR REPLACEMENT SW-V GOLD COPING

    MDR report key: 6960790 · Received October 19, 2017

    Report

    Report Number
    0001038806-2017-00732
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Report Date
    November 28, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK953101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ZIMMER REPLACEMENT SCREW WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED SIGNS OF WEAR FROM USE ABOUT THE THREADS AND INTERNAL DRIVE FEATURE. 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. PROBABLE CAUSES 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: REPORT DATE. DESCRIBE EVENT OR PROBLEM. BRAND NAME. CATALOG NUMBER.DATE RECEIVED BY MFR. ADDITIONAL 510K NUMBER: K011038. TYPE OF REPORTS. IF FOLLOW UP, WHAT TYPE? DEVICE EVALUATED BY MANUFACTURER? EVALUATION CODES. ADDITIONAL 510K NUMBER: K011038.

    Additional Manufacturer Narrative · 1

    PATIENT'S AGE, DATE OF BIRTH AND WEIGHT NOT PROVIDED/ UNKNOWN. EVENT DATE NOT PROVIDED/ UNKNOWN. DEVICE LOT NUMBER NOT PROVIDED/UNKNOWN.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE REPLACEMENT SCREW (GPCAS) LOOSENED. THE SCREW WAS REMOVED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE REPLACEMENT SCREW (MHLAS) LOOSENED. THE SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740152 SCR REPLACEMENT SW-V GOLD COPING REPLACEMENT SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1