BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK TITANIUM ABUTMENT 4.1MM

    MDR report key: 17406992 · Received July 27, 2023

    Report

    Report Number
    0001038806-2023-01412
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Report Date
    December 17, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868031628
    PMA / PMN Number
    K052648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) LDAT4, BELLATEK® TITANIUM ABUTMENT 4.1MM 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 (8831064-1). 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 THIS COMPLAINT IS NOT PERFORMED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. 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 (IMAGE I). NO DISCREPANCIES WERE OBSERVED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00057-HAZ REV.20/PROJECT 766 REV.05, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS SCREW LOOSENING DUE TO INSUFFICIENT TORQUE. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D4: DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT CALLED IN TO ADVISE IMPLANT THAT WAS IMPLANTED IN SITE 18/19 IN 1995 WAS A 4.1X11 (IMPLANT WAS A 4.1X13) THE ABUTMENT BROKE AT HEX AND HAD TO BE REPLACED. (SEE EVENT CE-06343-2023) CURRENTLY, JOB 8831064 IS NEW CASE. PATIENT REPORTED THE ABUTMENT IS NOT SECURE IT IS ROCKING IN SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232499 BELLATEK TITANIUM ABUTMENT 4.1MM DENTAL ABUTMENT NHA BIOMET 3I 8831064-1 00844868031628

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male