BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12221484 · Received July 23, 2021

    Report

    Report Number
    0002023141-2021-01908
    Event Type
    Injury
    Date Received
    July 23, 2021
    Report Date
    December 8, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10 X 3) AND MOUNTS WERE REPORTED BUT ONLY TWO IMPLANTS WITH ONE MOUNT AND ONE COVER SCREW WERE RETURNED FOR INVESTIGATION. THERE WERE NO ALLEGATIONS AGAINST THE COVER SCREW AND NO MALFUNCTION WAS IDENTIFIED. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED NO APPARENT MALFUNCTION FOR THE RETURNED IMPLANTS BUT THE MOUNT HEX WAS FRACTURED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE PRODUCTS WERE INTENDED FOR UNKNOWN TOOTH LOCATIONS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOTS: (1236002 & 1240889) 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 ZIMMER BIOMET. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS: (1236002 & 1240889) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR FOR THE RETURNED MOUNT AND MOUNT FRACTURE WAS CONFIRMED; DEVICE MALFUNCTION DID NOT OCCUR FOR THE RETURNED IMPLANTS AND IMPLANT FRACTURE WAS UNCONFIRMED. ADDITIONALLY, DEVICE MALFUNCTION AND THE REPORTED EVENT (IMPLANT FRACTURE) COULD NOT BE VERIFIED FOR THE THIRD REPORTED IMPLANT SINCE IT WAS NOT RETURNED. 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 "YES" TO "NO". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT IDENTIFIER: NOT PROVIDED. EVENT DATE: NOT PROVIDED. PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO FIXTURE COPING/ MOUNT AND IMPLANT CONNECTION FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114191 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1240889 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention