BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® HEXED SCREW

    MDR report key: 6567509 · Received May 15, 2017

    Report

    Report Number
    0001038806-2017-00236
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    February 3, 2017
    Report Date
    October 16, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) CERTAIN® GOLD-TITE® HEXED SCREW WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE SCREW COLLAR, DRIVE FEATURE, AND BODY ARE NOTED TO BE ONLY SLIGHTLY WORN, INDICATING USE. THE DRIVE FEATURE IS INTACT AND FUNCTIONAL. THEREFORE THE COMPLAINT COULD NOT BE VERIFIED. 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: BIOMET 3I RESTORATIVE MANUAL INSTRM REV C 09/16. THE BIOMET 3I RESTORATIVE MANUAL WAS CONFIRMED TO CONTAIN INSTRUCTION ON SCREW PLACEMENT AS WELL AS RECOMMENDED TORQUE VALUES. IN THE CASE OF CERTAIN® GOLD-TITE® HEXED SCREW IT IS RECOMMENDED TO TORQUE AT 20NCM. PROBABLE CAUSES FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED.

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER NOT PROVIDED/UNKNOWN.

    Additional Manufacturer Narrative · 1

    FOLLOWING THE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER THIS EVENT NO LONGER MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. AS A RESULT THE PRIOR SUBMISSIONS FOR MFR- 0001038806-2017-00236 SUBMITTED ON MAY 15, 2017 AND MFR- 0001038806-2017-00236-1 SUBMITTED ON JULY 20, 2017 ARE NO LONGER CONSIDERED REPORTABLE EVENTS BY THE MANUFACTURE AND NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THEY WERE PATIENT WAS PRESENTED WITH A LOOSE IUNIHG ABUTMENT SCREW AND DOES NOT RETAIN THE ABUTMENT. (B)(6). NO FURTHER CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IN FOLLOW-UP PHONE CONVERSATION WITH CUSTOMER IT WAS CLARIFIED THAT THE ABUTMENT SCREW WAS SENT BECAUSE THEY WERE INFORMED THAT WARRANTY APPLIES TO THE SCREWS WHEN BEING SENT IN CONJUNCTION TO AN IMPLANT. THE CUSTOMER WAS UNAWARE AT THE TIME THEY SENT THE IMPLANTS AND THEY SET THE SCREWS AFTER REALIZING THIS FACT. THEREFORE THIS IS NO REPORTED MALFUNCTION WITH THE RETURNED ABUTMENT SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348368 CERTAIN® GOLD-TITE® HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR