BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,13

    MDR report key: 13116655 · Received December 30, 2021

    Report

    Report Number
    0002023141-2021-03729
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    October 26, 2021
    Report Date
    June 30, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019249
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). TWO IMPLANTS WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND EXCESSIVE BONE HOWEVER NO DAMAGE IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THE RETURNED DEVICE WAS MEASURED WITH A CALIPER (CAL1831 (DUE: SEP 2, 2022) AND VERIFIED TO MATCH DHR DRAWING NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICES WAS LOCATED ON TOOTH #34 AND #35 AND WAS USED FOR APPROXIMATELY 1 MONTH. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9 ¿ 10/19 INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1242679 AND 1218633). 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 WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (OP160 & OP150) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242679 AND 1218633) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: PAIN POST MARKET TREND REVIEW: APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER: (B)(6). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER:K011028 AND K013227.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE DOCTOR REPORTED THAT THE IMPLANTS LOCATED IN DENTAL POSITIONS #4 AND 35 FAILED BECAUSE THE PATIENT CAME FOR REVIEW AFTER 3 WEEKS AND COMPLAINED OF PAIN. THE IMPLANTS HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017952 IMP,TSV,4.1MM,SBM,13 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B13 1242679 00889024019249

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention