BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1,10,MTX,MG

    MDR report key: 11286362 · Received February 5, 2021

    Report

    Report Number
    0002023141-2021-00306
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 14, 2021
    Report Date
    May 7, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019829
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSVT4B10) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THE MOUNT SCREW HEX WAS ROUNDED AND MOUNT WAS ENGAGED TO IMPLANT. ADDITIONALLY, THERE WAS BLOOD/BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. FUNCTIONAL TESTING WAS PERFORMED TO DISENGAGE MOUNT AND IMPLANT. THAT WAS UNSUCCESSFUL AS THE SCREW HEX WAS ROUNDED. PRE-EXISTING CONDITIONS NOTED ON THE PER WAS MODERATE BONE DENSITY ¿ TYPE II. THE REPORTED DEVICES WERE BEING PLACED ON TOOTH #19 (UNIVERSAL) WHEN THE INCIDENT OCCURRED. X-RAY/PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1233728) 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 (1233728) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MAIL FORM THE DOCTOR'S OFFICE. PER REPORTS: THE FIXTURE MOUNT TRANSFER WOULD NOT DISENGAGE THE IMPLANT DURING SURGERY. IMPLANT WAS REMOVED, TOOTH LOCATION # 19. NEW IMPLANT WAS PLACED. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183386 IMP,TSV,4.1,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1233728 00889024019829

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention