BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 15959837 · Received December 12, 2022

    Report

    Report Number
    0002023141-2022-03076
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    October 6, 2022
    Report Date
    March 29, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019928
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,3.7,10,MTX,MG (B)(6) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. NO APPARENT MALFUNCTION WAS NOTICED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. IMPLANT MATCHED PRINTS WHERE MEASURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 13 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 3 MONTHS, 26 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1251903). 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1251903) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (NON INTEGRATION PERFORATED SINUS) OR PRODUCT (TSVTB10). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT WAS NON-VERIFIABLE WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED IMPLANT #12, 13 WAS PLACED INCLUDING VERTICAL SINUS LIFT ON #13. PRIMARY STABILITY ON #12 WAS 35 NCM. PATIENT CAME BACK 4 MONTHS AFTER PLACEMENT FOR UNCOVERY. #12 UNCOVERED AND TORQUE TESTED TO 35 NCM AND PASSED AND #13 WAS SPINNING AND WAS LOOSE WITH GRANULATION TISSUE AROUND IT. IMPLANT #13 TAKEN OUT AND GRAFTED THE SITE FOR FUTURE IMPLANT REPLACEMENT. TOOTH #13. ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT REPLACEMENT #13. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, OTHER: GRANULATION TISSUE.

    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
    406394 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB10 1251903 00889024019928

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention