BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 10407928 · Received August 14, 2020

    Report

    Report Number
    0002023141-2020-01247
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    June 15, 2020
    Report Date
    March 24, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE IMP,TSV,4.1MM,SBM,11.5 (TSV4B) WAS REPORTED. ALTHOUGH THE MANUFACTURER (ZB EU AUTHORIZED REPRESENTATIVE) HAS RECEIVED THE PRODUCT, THE MANUFACTURING/INVESTIGATION SITE HAS NOT RECEIVED/EVALUATED THE ACTUAL DEVICE DUE TO COVID PROTOCOLS AND DELAYS IN SHIPMENT. THE PRODUCT HAS NOT BEEN PHYSICALLY INSPECTED AS PRODUCT FOR THIS COMPLAINT HAS BEEN LOST IN TRANSIT BY THE SHIPPER (UPS) AND A CLAIM HAS BEEN FILED TO LOCATE THE BOX. PRODUCT HAS NOT ARRIVED IN PALM BEACH GARDENS. TRACKING (B)(4). NO PER WAS PROVIDED AND NO PRE-EXISTING CONDITIONS WERE NOTED. THE PATIENT HAD MODERATE (TYPE II) BONE DENSITY AND THE REPORTED IMPLANT WAS USED DURING THE SINGLE DAY/PROCEDURE ON TOOTH 46 (FDI) WHILE THE DRIVER WAS USED FOR AN UNKNOWN DURATION. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR XRAYS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230952). 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 (1230952) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DAMAGED DRIVE FEATURE) OR REPORTED DEVICE (TSV4B11). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON VERIFIABLE FOR BOTH DEVICES AS NO OBJECTIVE EVIDENCE WAS PROVIDED TOWARDS THE REPORTED EVENT AND PRODUCT HAS NOT BEEN PHYSICALLY INSPECTED FOR THIS COMPLAINT HAS BEEN LOST IN TRANSIT BY THE SHIPPER.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE IMP,TSV,4.1MM,SBM,11.5 (TSV4B11) WITH IT'S BUNDLED MOUNT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE IDENTIFIED SIGNS OF USE, DRIED BLOOD AND BONE AND THE IMPLANT'S HEX FEATURE IS DAMAGED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PER WAS PROVIDED AND NO PRE-EXISTING CONDITIONS WERE NOTED. THE PATIENT HAD MODERATE (TYPE II) BONE DENSITY AND THE REPORTED IMPLANT WAS USED DURING THE SINGLE DAY/PROCEDURE ON TOOTH 46 (FDI) WHILE THE DRIVER WAS USED FOR AN UNKNOWN DURATION. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR XRAYS. TSV4B11 REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9 ¿ 10/19 INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, GENERAL CONSIDERATIONS AND ADVERSE EFFECTS DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230952). 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 (1230952) 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 (DAMAGED DRIVE FEATURE) OR REPORTED DEVICE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR FOR THE RETURNED TSV4B11 IMPLANT AND COULD NOT BE VERIFIED FOR THE REPORTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMLPANT WAS REMOVED DUE TO DAMAGE CONNECTION.NO OTHER IMPLANT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872483 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1230952 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention