BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD-TITE® HEXED RETAINING SCREW - 3MM

    MDR report key: 12263579 · Received August 2, 2021

    Report

    Report Number
    0001038806-2021-01424
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Report Date
    April 11, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868003984
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOLD-TITE® HEXED RETAINING SCREW - 3MM (GSH30) WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES TO ADDRESS REPORTED EVENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE NOT RETURNED. PRE-EXISTING CONDITION, TOOTH LOCATION AND PLACEMENT DURATION WERE UNKNOWN DUE TO LIMITED INFORMATION PROVIDED BY CUSTOMER. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1236724). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1236724) FOR SIMILAR EVENT USING AND NO OTHER COMPLAINTS WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENTS COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NON-VERIFIABLE AND THE PRODUCTS WERE NOT RETURNED. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    BASED ON UPDATED CUSTOMER INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT MFR REPORT NUMBER 0001038806-2021-01424 AND 0001038806-2021-01424-1 WERE REPORTED IN ERROR. PLEASE DISREGARD THESE SUBMISSIONS. NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP."

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEXED RETAINING SCREW FRACTURED. THEY ALREADY ORDERED REPLACEMENT SCREW. TOOTH LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155419 GOLD-TITE® HEXED RETAINING SCREW - 3MM DENTAL SCREW NHA BIOMET 3I GSH30 1236724 00844868003984

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose