BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 13MM

    MDR report key: 12351087 · Received August 20, 2021

    Report

    Report Number
    0002023141-2021-02257
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 22, 2021
    Report Date
    January 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020115
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 13MM (TSVWH13) IMPLANT WITH MOUNT AND STUCK TOOL IMPLANT REMOVAL SCR TYPE IMP (IRT) WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURED MOUNT HEX AND STUCK TOOL TO THE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. PRE-EXISTING CONDITIONS WERE UNKNOWN. TOOTH SITE WAS 19 UNIVERSAL AND THE ISSUE OCCURRED DURING THE CLINICAL PROCEDURE, PLACED AND REMOVED SAME DAY. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1241001. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. HOWEVER, THE DHR COULD NOT BE REVIEWED FOR THE IRT SINCE THE LOT NUMBER WAS UNKNOWN. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241001) FOR SIMILAR EVENTS USING AND NO OTHER COMPLAINT WAS IDENTIFIED. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (IRT) DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAD OCCURRED AND REPORTED EVENTS WERE CONFIRMED.

    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). PMA/510K: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PLACEMENT THE FIXTURE MOUNT FRACTURED IN THE IMPLANT. THE DOCTOR USED AN IRT TO REMOVED THE FRACTURED PORTION OF THE MOUNT FROM THE IMPLANT, AND THE IRT GOT STUCK. THE IMPLANT HAD TO BE REMOVED. THEY USED ANOTHER IMPLANT TO COMPLETE THE PROCEDURE. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED. TOOTH LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246552 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWH13 1241001 00889024020115

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose