BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

    MDR report key: 12506301 · Received September 21, 2021

    Report

    Report Number
    0002023141-2021-02614
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    July 16, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343887
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH (CT3111) AND COVER SCREW WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. HOWEVER, ONE UNKNOWN ZIMMER ABUTMENT WAS NOT RETURNED AND VISUALLY EVALUATION COULD NOT BE PERFORMED. THE IMPLANT WAS ABLE TO ASSEMBLE AND DISASSEMBLE WITH AN IN-HOUSE MATING ABUTMENT AS NORMAL. MEASUREMENTS WERE TAKEN USING A CALIPER (ID: CAL1831; DUE: SEP 2, 2022). THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS WHEN IT LEFT ZIMMER BIOMET. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE DEVICES WERE INTENDED FOR AN UNKNOWN TOOTH LOCATION. X-RAY & PICTURE EVALUATION: X-RAY IMAGES WERE PROVIDED MIGRATION WAS CONFIRMED FOLLOWING THE EVALUATION. THE DOCTOR CONFIRMED THAT THE IMPLANT HAD ACHIEVED PRIMARY STABILITY BUT MOVED FURTHER UP WHEN EXCESSIVE FORCE WAS APPLIED WHILE ATTEMPTING TO PLACE THE PROVISIONAL ABUTMENT (FILES: MIGRATION-X-RAY & MIGRATION-X-RAY). REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: INSTRUCTIONS FOR USE ¿ IMPLANTS, ABUTMENTS AND RESTORATIVE COMPONENTS FOR 3.1MMD EZTETIC IMPLANT, IFU9228 REV 1 ¿ 11/19. INFORMATION IDENTIFIED: INDICATIONS, WARNINGS AND PRECAUTIONS. PER THE APPLICABLE IFU, IMPROPER TECHNIQUES CAN LEAD TO DEVICE FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT: (1242327) 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. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1242327) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: MIGRATION & DOES NOT SEAT) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: OCTOBER 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 AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR FOR THE IMPLANT AND COULD NOT BE VERIFIED FOR THE ABUTMENT. THE REPORTED MIGRATION WAS CONFIRMED THROUGH X-RAY EVALUATION BUT DOES NOT SEAT EVENT COULD NOT BE VERIFIED SINCE THE ABUTMENT WAS NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT, IT HAD ACHIEVE PRIMARY STABILITY AND DOCTOR PROCEEDED TO PLACE THE PROVISIONAL ABUTMENT. DOCTOR WAS NOT ABLE TO PLACE THE ABUTMENT AND WHILE ATTEMPTING TO DO SO EXCESSIVE FORCE WAS APPLIED AND IMPLANT WAS DISPLACED. IMPLANT. IMPLANT WAS REMOVED THE FOLLOWING DAY AS THE PATIENT HAD TO LEAVE THE PRACTICE, AFTER REMOVAL GUIDED BONE REGENERATION AND L-PRF IN THE ALVEOLUS. INFLAMMATION WAS REPORTED AS A CONSEQUENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407333 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CT3111 1242327 00889024343887

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention