BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ TITANIUM LARGE HEXED SCREW

    MDR report key: 17408462 · Received July 27, 2023

    Report

    Report Number
    0001038806-2023-01414
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    May 14, 2023
    Report Date
    January 29, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868006138
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: REPORTER NAME AND EMAIL ADDRESS UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K972444/K072642.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (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, A FRACTURE HAS BEEN IDENTIFIED AT THE THREADS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1217797. 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 1217797 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : SCREW BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WERE MATERIAL SELECTION OF THE PRODUCT IS NOT ADEQUATE TO WITHSTAND OCCLUSAL FORCES. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON THE THREADS. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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

    IT WAS REPORTED THAT 3 SCREWS AT TOOTH SITES 13, 14 AND 16 FRACTURED AND HAD TO BE REMOVED.

    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
    1223018 CERTAIN¿ TITANIUM LARGE HEXED SCREW DENTAL SCREW NHA BIOMET 3I 1217797 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Male