BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.1MM,10M

    MDR report key: 11527270 · Received March 19, 2021

    Report

    Report Number
    0002023141-2021-00696
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    June 26, 2020
    Report Date
    June 16, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019621
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: H10: ADDITIONAL NARRATIVE ONE TAPERED SCREW-VENT IMPLANT (TSVM4B10) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THE MOUNT HEX WAS FRACTURED. ADDITIONALLY, THERE WAS BLOOD/BONE RESIDUE AROUND THE EXTERNAL THREADS OF THE IMPLANT DUE TO USAGE. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1232638) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT (1232638) FOR SIMILAR EVENTS 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    DOCTOR REPORTED MOUNT FRACTURE DURING IMPLANT PLACEMENT. DR. HAS FINISHED THE PROCEDURE WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422710 IMP,TSV,MCOL MG,4.1MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL TSVM4B10 1232638 00889024019621

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR