BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 15735598 · Received November 4, 2022

    Report

    Report Number
    0002023141-2022-02782
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Report Date
    March 9, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER: K101880.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: EXPIRATION DATE AND UDI NOT AVAILABLE, LOT NUMBER UNKNOWN. 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'. H4: DEVICE MANUFACTURE DATE NOT AVAILABLE, LOT NUMBER UNKNOWN. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. IT WAS REPORTED THAT THE BUNDLE MOUNT FRACTURED INSIDE OF AN IMPLANT AND THAT THE DRIVER FRACTURED INSIDE OF AN ABUTMENT. TWO MOUNTS AND ONE DRIVER WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED PRODUCTS IDENTIFIED THE HXGR1.25 DRIVER IS FRACTURED AT THE TIP AND THAT ONE OF THE MOUNTS (FMT4) HAD A FRACTURED HEX CONNECTION, WHILE THE OTHER HAD NO MALFUNCTION. THE TSVMWB10 WAS NOT RETURNED AS IT REMAINS IMPLANTED, SO VISUAL EVALUATION COULD NOT BE COMPLETED, AND MALFUNCTION COULD NOT BE VERIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES & EVENT. PREEXISTING CONDITION NOTED WAS UNKNOWN BONE DENSITY. THE REPORTED DEVICES WERE AT AN UNKNOWN TOOTH LOCATION. ADDITIONALLY, IT IS NOT KNOWN HOW LONG THE MOUNTS AND THE DRIVER WERE IN USE. THE CUSTOMER DID NOT PROVIDE X-RAYS OR IMAGES. DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS (IFU4869 REV 9 10/2019). ZIMMER® INSTRUMENT KIT SYSTEM, DENTAL SINGLE PATIENT DRILLS, DRIVA¿ DRILLS, AND TOOLS (IFU8874 REV 5 08/2019). INFORMATION IDENTIFIED: 'WARNINGS' 'PRECAUTIONS' 'STERILITY' 'POTENTIAL ADVERSE EVENTS' DHR AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED DATING BACK TO 12 MONTHS PRIOR TO THE NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICES RELATED TO THE REPORTED EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: 'FRACTURE' DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE TSVMWB10 WAS NOT RETURNED, SO DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED ABUTMENT (MULTIPLE USES MOUNT) FRACTURED INSIDE OF THE IMPLANT (80 NEW TORQUE) AND DRIVER FRACTURED INSIDE OF ABUTMENT. PROCEDURE HAS NOT BEEN COMPLETED WITH OTHER DEVICES.

    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
    2228047 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HXGR1.25FMT4