BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TM 3.7MM MTX,10MM

    MDR report key: 14956168 · Received July 8, 2022

    Report

    Report Number
    0002023141-2022-01755
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    June 10, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018860
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G3: DATE RECEIVED BY THE MANUFACTURER H1: TYPE OF REPORT, FOLLOW-UP NUMBER H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' H6: EVALUATION CODES H10: ADDITIONAL NARRATIVE ONE IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED IMPLANT FRACTURED AT THE COLLAR REGION. SIGNS OF USE. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS FRACTURED. PRE-EXISTING CONDITIONS NOTED ON THE PER WERE 'LOW BONE DENSITY ¿ TYPE III'. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH 32 (FDI) FOR APPROXIMATELY 5 MONTHS. THE PATIENT IS A SMOKER X-RAY & PICTURE EVALUATION: PICTURE OR X-RAY EVIDENCE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS & PRECAUTIONS. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES, SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. DHR REVIEW: DHR REVIEW FOR THE LOT (1232699) 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1232699) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: IMPLANT) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: OCTOBER 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 DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT AN IMPLANT FRACTURE AT TOOTH SITE #32.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851146 IMP,TM 3.7MM MTX,10MM DENTAL IMPLANT DZE ZIMMER DENTAL TMMB10 1232699 00889024018860

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention