BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 15552249 · Received October 6, 2022

    Report

    Report Number
    0002023141-2022-02522
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    February 15, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020054
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K013227.

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM (TSVWB11) WAS RETURNED FOR INVESTIGATION. BONE DEBRIS ON EXTERNAL THREADS. UNABLE TO IDENTIFY ANY FRACTURES ON THE IMPLANT. ATTEMPTED TO DISENGAGE MOUNT FROM IMPLANT FOR FURTHER INSPECTION OF THE IMPLANT FOR FRACTURES. USED AN IN-HOUSE DRIVER TO DISENGAGE THE MOUNT FROM THE IMPLANT. HOWEVER, THE MOUNT WOULDN¿T DISENGAGE FROM THE IMPLANT AS INTENDED. WHEN ROTATING THE DRIVER COUNTERCLOCKWISE THE SCREW INSIDE UNSCREWED, HOWEVER AFTER A COUPLE OF TURNS IT BEGAN TO MAKE A CLICKING SOUND AND IT WOULDN¿T RELEASE FROM THE IMPLANT. MALFUNCTION. BONE LOSS COULD NOT BE VERIFIED. SUMMARY INVESTIGATION ATTACHED IN COMPLAINT. FUNCTIONAL TESTING PERFORMED AND MOUNT COULD NOT DISENGAGE. PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY - TYPE II. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #30 FOR APPROXIMATELY 3 YEARS. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1240794) 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 ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240794) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. DECEMBER 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, THE PRODUCT WAS RETURNED, AND THE REPORTED EVENT (FRACTURE) WAS UNCONFIRMED FOLLOWING VISUAL EVALUATION. HOWEVER, DEVICE MALFUNCTION (DOES NOT DISENGAGE/RELEASE) DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED. BONE LOSS COULD NOT BE VERIFIED. SUMMARY INVESTIGATION ATTACHED IN COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CROWN CAME LOOSE. BONE LOSS ON MESIAL. IMPLANT #30. FRACTURE OF IMPLANT ON MESIAL RIM. REMOVED IMPLANT, DEBRIDEMENT AND GRAFTING. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888345 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB11 1240794 00889024020054

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention