BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH

    MDR report key: 11364629 · Received February 23, 2021

    Report

    Report Number
    0002023141-2021-00444
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    August 12, 2020
    Report Date
    May 20, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343917
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE EZTETIC DENTAL IMPLANT (CT318) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO FRACTURE. THE DEVICE HAD MINIMAL DAMAGES AND BONE RESIDUE AROUND THE EXTERNAL THREADS ¿ DAMAGE WAS POSSIBLY SUSTAINED DURING THE REMOVAL PROCESS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS NOT PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH # 13 (UNKNOWN NOTATION SYSTEM) FOR APPROXIMATELY 1 YEAR. X-RAY/PICTURE EVALUATION: NONE PROVIDED BY THE CUSTOMER. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT: (1221318) 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. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT: (1221318) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. 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). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT FRACTURED AT TOOTH LOCATION # 13. IMPLANT AVULSED. WILL REPLACE. 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
    261047 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CT318 1221318 00889024343917

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention