BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,3.7MM,10M

    MDR report key: 14369628 · Received May 12, 2022

    Report

    Report Number
    0002023141-2022-01160
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    March 21, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019720
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMP, TSV, MCOL MG,3.7MM,10M (TSVMB10) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED FRAGMENT OF THE MOUNT HEX IN THE IMPLANT DRIVE FEATURE. ADDITIONALLY, THERE WAS BLOOD/BONE RESIDUE AROUND THE EXTERNAL THREADS OF THE IMPLANT DUE TO USAGE. THE IMPLANT COLLAR WAS SEVERELY DAMAGED POSSIBLY DUE TO THE REMOVAL PROCESS. DAMAGE OBSERVED ON RETURNED IMPLANTS DUE TO TREPHINE REMOVAL IS NOT CONSIDERED A MALFUNCTION OR FAILURE OF THE DEVICE. ZIMVIE IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1250066) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCE'S WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1250066) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: MOUNT) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE REPORTED MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURE OF THE HEXAGON INSIDE OF THE IMPLANT WHILE PLACING IT. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.

    Description of Event or Problem · 0

    AFTER THE INVESTIGATION RESULTS, A FRAGMENT OF THE MOUNT HEX HAS BEEN IDENTIFIED IN THE IMPLANT DRIVE FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040704 IMP,TSV,MCOL MG,3.7MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL TSVMB10 1250066 00889024019720

    Patients

    Seq Age Sex Outcome Treatment
    1 Female