BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 9227229 · Received October 23, 2019

    Report

    Report Number
    0002023141-2019-00960
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: DATE OF REPORT. UDI, EXPIRATION DATE. DATE RECEIVED BY MANUFACTURER. ADDITIONAL 510K NUMBER: K101880. CHECKED "FOLLOW-UP". CHECKED FOLLOW-UP TYPE. DEVICE EVALUATION CHECKED "YES". DEVICE MANUFACTURER DATE. ENTERED EVALUATION CODES. ADDED MANUFACTURER NARRATIVE. THE IMPLANT AND A NON-ZIMMER TOOL WERE RETURNED. HOWEVER, THE REPORTED SCREW FRACTURE COULD NOT BE VERIFIED. THE IMPLANT DRIVE FEATURE COULD NOT BE INSPECTED FOR THE PRESENCE OF SCREW REMAINS SINCE THE TOOL WAS STUCK. BASED ON THE EVALUATION, THE REPORTED MALFUNCTION COULD NOT BE VERIFIED. DHR REVIEW FOR THE LOT 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 REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510(K) NUMBER IS K101880.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE COPING SCREW BROKE DURING PLACEMENT OF TSVTWB11 IMPLANT. DOCTOR WAS UNSURE IF ALL OF THE SCREW CAME OUT OF THE IMPLANT. DOCTOR REMOVED THE IMPLANT AND WAS ABLE TO COMPLETE THE PROCEDURE PLACING A NEW IMPLANT THAT DAY. TOOTH SITE #14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023200 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1218501

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR