BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL PLACEMENT TOOL

    MDR report key: 12452504 · Received September 10, 2021

    Report

    Report Number
    0002023141-2021-02523
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    July 19, 2021
    Report Date
    February 4, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    Adverse Event
    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 MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS RETURNED FOR INVESTIGATION. HOWEVER, ONE UNKNOWN PLACEMENT TOOL WAS REPORTED BUT NOT RETURNED. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF USE WITH SOME DEBRIS ON THE THREADS AND DRIED BLOOD INSIDE DRIVE FEATURE BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED USING COMPATIBLE IN-HOUSE DRIVER. THE DEVICE WAS ABLE TO ENGAGE, RETAIN AND DISENGAGE AS NORMAL. PRE-EXISTING PATIENT CONDITIONS, TOOTH LOCATION, IMPLANTATION PERIOD AND X-RAY IMAGES ARE IRRELEVANT TO THIS INVESTIGATION. PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241484). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURES. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTED AS PART OF THE DHR. HOWEVER, DHR REVIEW COULD NOT BE PERFORMED FOR THE UNKNOWN PLACEMENT TOOL AS THE ITEM/LOT NUMBER WAS UNKNOWN. COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241484) AND NO OTHER COMPLAINT WAS IDENTIFIED. COMPLAINT HISTORY FOR THE UNKNOWN PLACEMENT TOOL COULD NOT BE PERFORMED AS THE ITEM/LOT NUMBER WAS UNKNOWN. BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION FOR IMPLANT DID NOT OCCUR. HOWEVER, DRIVER MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED SINCE THE DRIVER WAS NOT RETURNED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES".

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT #6 DURING INSERTION CAME OFF FROM THE INSERTING TOOL AND FELL IN THE MOUTH. IMPLANT WAS REMOVED, ANOTHER IMPLANT WAS NOT PLACED. PATIENT RETURNING FOR DIFFERENT SIZE IMPLANT PLACEMENT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350952 DENTAL PLACEMENT TOOL NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention