BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 11582510 · Received March 29, 2021

    Report

    Report Number
    0001038806-2021-00515
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    October 27, 2020
    Report Date
    August 17, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA, ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DEVICE AVAILABILITY AND RETURN DATE WAS UPDATED. D10: ILDAT5, CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM-LOT# 8546668-1 WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4111 AND 4110. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67 AND 4315. H10: NARRATIVE/DATA WAS UPDATED. THE PRODUCT WAS RETURNED AND THE REPORTED EVENT (LOOSENING) COULD NOT BE VERIFIED, AS THE EXACT DETAILS OF DEVICE USAGE AND THE PATIENT¿S ANATOMICAL CONDITIONS WERE UNKNOWN. BASED ON THE EVALUATION THE DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICES. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1231516¿ IUNIHG). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, 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. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (8546668-1 ¿ ILDAT5). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, 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. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE IUNIHG DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. A LOT SPECIFIC COMPLAINT HISTORY REVIEW IS NOT CONDUCTED FOR PSP COMPLAINTS. PATIENT SPECIFIC PRODUCTS HAVE A UNIQUE ONE TIME USE LOT NUMBER. THEREFORE, A LOT SPECIFIC HISTORY SEARCH FOR ITEM (ILDAT5) IS NOT PERFORMED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (LOOSENING) AND THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK REVIEW, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS CUSTOMER ERROR IN SCREW TORQUEING AND/OR EXTERNAL FORCES FROM PATIENT PARAFUNCTION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DEVICE DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCREW HAS BECOME LOOSE AFTER THE CROWN WAS SEATED. TOOTH #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478000 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1231516 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 DENTAL ABUTMENT-SEE H10 NARRATIVE