BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 15292430 · Received August 25, 2022

    Report

    Report Number
    0002023141-2022-02192
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    June 13, 2022
    Report Date
    January 18, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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,4.1MM,SBM,11.5 (TSV4B11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH SIGNS OF USE, DEBRIS ATTACHED TO EXTERNAL TREADS. NO APPARENT MALFUNCTION WAS NOTICED DURING PRODUCT EVALUATION, 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 MODERATE BONE DENSITY (TYPE II). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 7 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 10 MONTHS, 23 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240254). 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 (1240254) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (MEDICAL OTHER) OR PRODUCT (TSV4B11). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED SINCE IT IS A MEDICAL CONDITION (PATIENT ANATOMICAL CONDITION AND DETAILS OF EVENT WERE UNKNOWN). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H3: CHANGED "NO" TO "YES" .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TOOTH#7 EXTRACTED AND IMMEDIATE IMPLANT PLACED. PATIENT HAVING DISCOMFORT ("PUSHING") BETWEEN #7/8. TOOK CBCT AND SHOW SUPERNUMERY TOOTH #57/58 BETWEEN #7/8 THAT DID NOT SHOW ON PANORAMIC X-RAY. TOOTH WAS COMPROMISING IMPLANT. AS SUCH IMPLANT WAS REMOVED, SUPERNUMERY EXTRACTED AND SITE GRAFTED FOR FUTURE RE-IMPLANT. PT HAD PREVIOUS IMPLANT #8 WHICH FAILED AND WAS REMOVED.

    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
    477725 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1240254 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention