BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 10884536 · Received November 23, 2020

    Report

    Report Number
    0002023141-2020-02061
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    September 2, 2020
    Report Date
    March 25, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019263
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER CMP-(B)(4). ONE IMP,TSV,4.1MM,SBM,8 (TSV4B8) WAS RETURNED FOR INVESTIGATION VISUAL INSPECTION OF THE AS RETURNED IMPLANT PACKAGING IDENTIFIED THAT ONLY THE FOLLOWING PACKAGING WAS RECEIVED FOR REPORTED IMPLANT: OUTER BOX, OUTER VIAL, AND IFU. THE OUTER VIAL SEAL WAS BROKEN WITHOUT ANY INNER VIAL, IMPLANT, MOUNT, OR SCREW RETURNED. FUNCTIONAL TESTING TO RECREATE THE REPORTED PACKAGING EVENT FOR THE IMPLANT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL IMAGES OF THE PRODUCTS ALONG WITH THE PER. PRE-EXISTING PATIENT FACTORS (UNKNOWN BONE DENSITY) AND TOOTH LOCATION (25, FDI) ARE NOT RELEVANT TO THE REPORTED EVENTS. THE CONDITIONS OF THE REPORTED PRODUCT WHEN IT FIRST REACHED THE CUSTOMER ARE UNKNOWN. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: 'INSTRUCTIONS FOR USE FOR ZIMMER® INSTRUMENT KIT SYSTEM, ZIMMER DENTAL SINGLE PATIENT DRILLS, DRIVA¿ DRILLS, AND TOOLS¿ 8874 REV 5 INFORMATION IDENTIFIED: INDICATIONS; PAGE 2 DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9 ¿ 10/19 INFORMATION IDENTIFIED: 'STERILITY' , 'PRODUCT PACKAGING' & 'INSERTION PROCEDURES (STEP 3 ¿ REMOVE THE INNER VIAL) & (STEP 4 ¿ REMOVE THE IMPLANT FROM THE INNER VIAL)' DHR REVIEWS WERE COMPLETED FOR THE SUBJECT LOT NUMBER (1221014). 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 EVENTS, WERE NOTED AS PART OF THE DHRS. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. ADDITIONALLY, THE DHR FOR LOT 1221014 WAS FURTHER REVIEWED TO FURTHER VERIFY THE CONFORMANCE OF THE PACKAGING FOR THE REPORTED DEVICE. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1221014) FOR SIMILAR EVENTS AND NO OTHER COMPLAINTS WERE IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT ( PACKAGING: INCORRECT COMPONENT QUANTITY) OR PRODUCTS (TSV4B8). THEREFORE, BASED ON THE AVAILABLE INFORMATION THE PACKAGING MALFUNCTION COULD NOT T BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE FOR THE TSV4B8 AS THE CONDITIONS OF THE PRODUCT WHEN IT FIRST REACHED THE CUSTOMER ARE UNKNOWN.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. IMPLANT DATE UNKNOWN / NOT PROVIDED. EXPLANT DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT, DOCTOR REALIZED THAT THE IMPLANT WAS MISSING, THERE WAS NOT INNER VIAL. PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348605 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B8 1221014 00889024019263

    Patients

    Seq Age Sex Outcome Treatment
    1