BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK¿ HYBRID BAR 5 IMPLANTS

    MDR report key: 21397862 · Received February 18, 2025

    Report

    Report Number
    0001038806-2025-00347
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868001683
    PMA / PMN Number
    K080864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED A3: GENDER: UNKNOWN / NOT PROVIDED A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED B3: DATE OF EVENT: UNKNOWN / NOT PROVIDED G4: PREMARKET IDENTIFICATION: K241032.

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) CSHY05, (BELLATEK® HYBRID BAR 5 IMPLANTS) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 8712586-1. 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 COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. 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. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BAR FRACTURED IN PATIENT¿S MOUTH BETWEEN TOOTH NUMBERS 20 AND 21. BAR WILL BE REMADE BEETWEN TOOTH-20,22,24,25,28.

    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
    1178847 BELLATEK¿ HYBRID BAR 5 IMPLANTS DENTAL BAR NHA BIOMET 3I 8712586-1 00844868001683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown