BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 18142116 · Received November 15, 2023

    Report

    Report Number
    0002023141-2023-03250
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 1, 2023
    Report Date
    April 24, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, SOME MARKINGS AROUND THE DRIVE FEATURE, LIKELY DUE FROM THE REMOVAL PROCESS HOWEVER, THE INTERNAL THREADS DID NOT APPEAR TO BE DAMAGED. ADDITIONALLY, DURING A FUNCTIONAL TEST WITH AN IN-HOUSE SCREW, THE SCREW THREADED AND UNSCREWED AS INTENDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250932. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1250932 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES, SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT HAS BEEN UNCONFIRMED FOLLOWING FUNCTIONAL TESTING AND PHYSICAL EVALUATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TEST, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS UNCONFIRMED WITH ALL THE AVAILABLE INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PLACING THE IMPLANT, THE INTERNAL HEX OF THE IMPLANT APPEARED DISTORTED. THE IMPLANT WAS REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329819 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1250932 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention UNKNOWN DENTAL SCREW