BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN¿ TITANIUM LARGE HEXED SCREW

    MDR report key: 21949423 · Received May 2, 2025

    Report

    Report Number
    0001038806-2025-00956
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    January 28, 2025
    Report Date
    July 31, 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 CMP-(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: ADDITIONAL DEVICE INFORMATION G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZIMVIE RECEIVED ONE (1) ILRGHT, CERTAIN TITANIUM LARGE HEXED SCREW FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. FRACTURE SCREW IDENTIFIED INSIDE IMPLANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1180734-CN. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1180734-CN FOR SIMILAR EVENTS AND ONE OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE: SCREW BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR. FRACTURE SCREW IDENTIFIED INSIDE IMPLANT. THE REPORTED EVENT WAS CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED, D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED. D10: CONCOMITANT MEDICAL PRODUCT: ILRGHT, CERTAIN TITANIUM LARGE HEXED SCREW, LOT: 1180734-CN, E1: REPORTER NAME: UNKNOWN / NOT PROVIDED, G4: PREMARKET IDENTIFICATION PMA/510(K) #: K072642, H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT PATIENT CAME TO CLINIC REFERRING MOBILITY OF CROWNS, DOCTOR NOTICED SCREW FRACTURE AT TOOTH SITES 36 AND 37. WHEN SCREWS COULD NOT BE REMOVED, IMPLANTS WERE REMOVED. NEW IMPLANTS WILL BE PLACED IN 9 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189473 CERTAIN¿ TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I 1180734-CN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention DENTAL SCREW SEE H10 NARRATIVE.