BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT DRIVER

    MDR report key: 19816316 · Received July 24, 2024

    Report

    Report Number
    0002023141-2024-02519
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    May 30, 2024
    Report Date
    December 16, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). A4: PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. D1: BRAND NAME IS NOT PROVIDED / UNKNOWN. D4: CATALOG NUMBER AND LOT NUMBER ARE NOT PROVIDED / UNKNOWN. D10: TMMB13, IMP TM 3.7MM MTX,13MM, LOT NUMBER 1232413. E1: INITIAL REPORTER¿S EMAIL ADDRESS IS NOT PROVIDED / UNKNOWN.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN DRIVER 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 AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED SINCE THE ITEM NUMBER OR LOT NUMBER ASSOCIATED TO THE ITEM WAS NOT PROVIDED. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW , THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PROBABLY 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 PRODUCT WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 DROPPED OFF ON THE FLOOR. THE IMPLANT DISENGAGED FROM THE DRIVER. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408447 DENTAL IMPLANT DRIVER NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female DENTAL IMPLANT| DENTAL IMPLANT