BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL ABUTMENT

    MDR report key: 16732172 · Received April 13, 2023

    Report

    Report Number
    0002023141-2023-01050
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    December 29, 2022
    Report Date
    November 5, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. ZIMVIE RECEIVED ONE IMPLANT FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. DUE TO THE PIECE IN THE IMPLANT BEING UNABLE TO BE IDENTIFIED, MALFUNCTION COULD NOT BE VERIFIED. DHR REVIEW AND COMPLAINT HISTORY REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBERS ASSOCIATED WITH THE REPORTED PRODUCTS ARE NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. TSVWB11, IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM/LOT NUMBER-1230281. PMA/510(K) NUMBER NOT AVAILABLE. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT THE IMPLANT CROWN FRACTURED AND A NEW RESTORATION WAS MADE. WHEN PLACING THE NEW RESTORATION, IT WAS UNABLE TO SEAT. THE ABUTMENT HEX WAS NOTED TO BE BROKEN INSIDE THE IMPLANT AT TOOTH LOCATION #30 AND THE IMPLANT WAS REMOVED. NO FURTHER IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979236 DENTAL ABUTMENT NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Prefer Not To Disclose Required Intervention DENTAL IMPLANT.