BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL DRIVER

    MDR report key: 15993145 · Received December 15, 2022

    Report

    Report Number
    0002023141-2022-03146
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    February 10, 2022
    Report Date
    April 6, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS RETURNED AND ONE UNKNOWN DRIVER WAS NOT RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED NO DAMAGE TO THE IMPLANT. FUNCTIONAL TESTING WAS PERFORMED WITH AN IN-HOUSE DRIVER AND THE IMPLANT AND MOUNT ENGAGED AND RETAINED ON THE DRIVER. PRE-EXISTING CONDITIONS NOTED ON THE PER WERE LOW BONE DENSITY ¿ TYPE III. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #4 (UNIVERSAL). X-RAY & PICTURE EVALUATION: PICTURE OR X-RAY EVIDENCE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1251442) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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 (1251442) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. FEB POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR (IMPLANT) AND COULD NOT BE VERIFIED (DRIVER) AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP." H3: CHANGED "YES" TO "NO."

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 DISENGAGED AND WAS REMOVED.  IMPLANT WAS CONTAMINATED DURING DELIVERY OF IMPLANT DROPPED. NEW IMPLANT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733975 DENTAL DRIVER NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male