BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK HYBRID BAR 4 IMPLANTS

    MDR report key: 21079906 · Received January 6, 2025

    Report

    Report Number
    0001038806-2025-00030
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 8, 2024
    Report Date
    March 19, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868001676
    PMA / PMN Number
    K080864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K241032.

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) CSHY04, (BELLATEK® HYBRID BAR 4 IMPLANTS) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED ON IMAGES RECEIVED. A SMALL FRACTURE CAN BE OBSERVED IN THE RETURNED PROSTHESIS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 8731083-1. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. 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 THE ABUTMENT WAS NOT PERFORMED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. DIGITAL DESIGN FILE WAS NOT NEEDED FOR THIS CASE. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER PROJECT 1166 REV 2, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION HAS OCCURRED. THE RETURNED BAR WAS OBSERVED TO BE FRACTURED. THE REPORTED EVENT HAS BEEN CONFIRMED. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FREE-END SADDLE OF THE BAR BROKE OFF AT SITE # 28-29 AREA. LAB WILL BE SENDING BACK AS WELL AS HAVING BAR REMADE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962346 BELLATEK HYBRID BAR 4 IMPLANTS DENTAL BAR NHA BIOMET 3I 8731083-1 00844868001676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose