BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 16473408 · Received March 2, 2023

    Report

    Report Number
    0002023141-2023-00705
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    January 3, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    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). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/ 510K: /K011028/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 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED SIGNS OF USE. THERE WAS DAMAGE FROM THE REMOVAL PROCESS. DAMAGE SEEN ON THE EXTERNAL THREADS AND COLLAR. THE IMPLANTS DRIVE FEATURE WAS DAMAGED. ZIMVIE IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS DAMAGED. PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #46 (FDI) FOR APPROXIMATELY 2 YEARS. DHR REVIEW FOR THE LOT NUMBER (1240410) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PRODUCTS WAS CONFORMING AT THE TIME IT LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240410) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: DAMAGED DRIVE FEATURE) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED FLARED COLLAR AND WAS REMOVED. NO OTHER IMPLANT HAS BEEN PLACED FOR THE MOMENT. #46.

    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
    2002939 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1240410 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention