BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 14281828 · Received May 4, 2022

    Report

    Report Number
    0002023141-2022-01069
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    February 8, 2022
    Report Date
    September 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM (TSVWB8) AND COVER SCREW WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF USE BUT APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED WITH ALL DEVICES. THE COVER SCREWS WERE ABLE TO SCREW INTO THE RETURNED IMPLANT AS NORMAL. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1250842) 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 ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1250842) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: DEVICE MALFUNCTION) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT HAS BEEN UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COVER SCREW COULD NOT BE SCREWED IN THE IMPLANT. NO OTHER IMPLANT WAS PLACED TO FINISH THE PROCEDURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617561 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB8 1250842 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention