BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK ZIRCONIA ABUTMENT TSV 3.5MM

    MDR report key: 23302034 · Received October 15, 2025

    Report

    Report Number
    0001038806-2025-02445
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    UDI-DI
    00844868038054
    PMA / PMN Number
    K080164
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4114, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4315. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE DID NOT RECEIVED THE REPORTED ABUTMENT 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. 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 THIS COMPLAINT IS NOT PERFORMED. LDA ABUTMENTS ARE SCANNED AND DESIGNED WITHIN THE LAB. ZIMMER BIOMET ONLY MILLS THE DESIGN RECEIVED THROUGH 3SHAPE SOFTWARE. THEREFORE, A COMPARISON BETWEEN THE CUSTOMER DESIGN AND THE PRODUCT SHOULD BE PERFORMED. IN THE EVENT THAT THE PRODUCT IS NOT AVAILABLE, THE ABUTMENT EXPORT MILLING FILE CAN BE USED FOR THE COMPARISON. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS EXCESSIVE OCCLUSAL FORCES. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. ONLY THE CROWN AND THE RETAINING SCREW WERE RETURNED, NOT THE FRACTURED ABUTMENT. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABUTMENT FRACTURED AT THE BASE. WILL BE REMAKING THE ABUTMENT IN TITANIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337519 BELLATEK ZIRCONIA ABUTMENT TSV 3.5MM DENTAL ABUTMENT NHA ZIMVIE US CORP LLC 8567177-1 00844868038054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown