BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK ABUTMENT TSV 4.5MM

    MDR report key: 19320686 · Received May 15, 2024

    Report

    Report Number
    0002023141-2024-01620
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    UDI-DI
    00844868038092
    PMA / PMN Number
    K071439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) TSVLDAT4, BELLATEK® ABUTMENT TSV 4.5MM 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 8844565-1. 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 REALGUIDE SOFTWARE. THEREFORE, A COMPARISON BETWEEN THE CUSTOMER DESIGN AND THE PRODUCT SHOULD BE PERFORMED, HOWEVER A DESIGN REVIEW WAS NOT NEEDED IN THIS CASE. PER DHR REVIEW, A MHLAS SCREW IS INCLUDED IN THIS BUNDLE, HOWEVER, NO PRODUCT WAS RETURNED FOR EVALUATION. THE SOLD PRODUCT PASSED ALL INSPECTIONS. (SEE IMAGES I, II AND III) BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER (B)(4), THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS POSSIBLY USER CAUSED. 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, G3: DATE RECEIVED BY MANUFACTURER, G6: CHECKED "FOLLOW-UP", H3: CHANGED "YES" TO "NO", H6: ENTERED EVALUATION CODES, H10: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PMA/510(K) NUMBER K143505.

    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 ABUTMENT CAME LOOSE IN THE PT¿S MOUTH IN JANUARY, BUT THE DR COULD NOT GET THE SCREW OUT. THE SCREW WAS NEVER LOOSE AND RETIGHTENED. THEY LEFT IT IN THE PT¿S MOUTH UNTIL MARCH THEY WERE ABLE TO REMOVE IT AT THAT POINT AND REMADE IT. IT IS NOT KNOWN IF THE OLD ABUTMENT WAS SALVAGED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358777 BELLATEK ABUTMENT TSV 4.5MM DENTAL ABUTMENT NHA ZIMMER DENTAL 8844565-1 00844868038092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose