BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 12738167 · Received November 2, 2021

    Report

    Report Number
    0002023141-2021-03095
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 14, 2021
    Report Date
    April 30, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,4.7,11.5,MTX,MG (TSVTWB11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT AND MOUNT. DURING FUNCTIONAL TESTING, DEVICES COULD NOT BE DISENGAGED. SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS PERFORMED. THE DEVICES WERE NOT ABLE TO DISENGAGE EACH OTHER SUCCESSFULLY. NO PRE-EXISTING CONDITION WAS NOTED, AND NO PER FORM WAS PROVIDED. BONE DENSITY TYPE IS UNKNOWN. THE REPORTED DEVICE WAS LOCATED ON TOOTH SITE #30, AND WAS PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1240919) 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 ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1240919) WAS PERFORMED FOR SIMILAR EVENTS AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR 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). PMA/510K: K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT PLACEMENT, UNABLE TO REMOVE FIXTURE MOUNT FROM IMPLANT. IMPLANT AT TOOTH SITE # 30 WAS REMOVED. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. 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
    1639340 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB11 1240919 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male