BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 16280367 · Received February 1, 2023

    Report

    Report Number
    0002023141-2023-00412
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    January 26, 2021
    Report Date
    June 1, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020030
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) TSVTWB8 (IMP, TSV, 4.7, 8, MTX ,MG) WAS RETURNED FOR INVESTIGATION. DEVICE WAS MEASURED WITH A CALIPER (CAL3839 DUE: AUG 30, 2023) AND MATCHED PRINT SPECIFICATIONS. NO MALFUNCTIONS DETECTED THAT COULD LEAD TO REPORTED EVENT. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (PAIN). PRE-EXISTING CONDITIONS NOTED ON THE PER WERE CLENCHING AND UNKNOWN BONE DENSITY. THE REPORTED DEVICE WAS AT TOOTH LOCATION 31 (UNIVERSAL) FOR APPROXIMATELY 7 DAYS. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER, 1241289. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD OP (B)(4) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. MARCH 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, DEVICE MALFUNCTION HAS NOT OCCURRED, AND THE REPORTED EVENT COULD NOT BE VERIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: CHANGED "NO" TO "YES".

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K101880.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED SEVERAL DAYS LATER DUE TO PAIN AND INSERTED ANOTHER. HAD TO GET A NEW IMPLANT A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733938 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB8 1241289 00889024020030

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention