BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN TITANIUM LARGE HEXED SCREW

    MDR report key: 22042309 · Received May 19, 2025

    Report

    Report Number
    0001038806-2025-01108
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    March 11, 2024
    Report Date
    August 18, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. E1: REPORTER NAME UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K072642. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZIMVIE RECEIVED ONE (1) FRAGMENT / PORTION OF THE ILRGHT, (CERTAIN TITANIUM LARGE HEXED SCREW) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICES IDENTIFIED THE FRACTURED SCREW FRAGMENT STUCK INSIDE THE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DEVICE HISTORY RECORD (DHR) REVIEW AND COMPLAINT HISTORY REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE ILRGHT DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE SCREW BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE EXCESSIVE OCCLUSAL FORCES - PATIENT FACTORS, OR CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    THE DOCTOR REPORTED A FRACTURE SCREW INSIDE THE IMPLANT; IT WAS NOT POSSIBLE TO REMOVE THE FRACTURE PORTION SO IT WAS DECIDED TO REMOVE THE IMPLANT USING TREPHINE. AFFECTED DENTAL POSITION: #44.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191549 CERTAIN TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention