BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL SCREW

    MDR report key: 13548987 · Received February 17, 2022

    Report

    Report Number
    0002023141-2022-00408
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    December 15, 2021
    Report Date
    July 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    AN IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM (TSV6B13) AND AN UNKNOWN ZIMMER SCREW WERE RETURNED FOR INVESTIGATION, SEE ATTACHED IMAGES A00- A01 IN THE COMPLAINT. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED BONE ATTACHED TO THE IMPLANT EXTERNAL THREADS. FRACTURE AT THE COLLAR AND SCREW FRACTURE FOUND INSIDE. NO PRE-EXISTING CONDITIONS NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH #30 AND WAS USED FOR APPROXIMATELY 3 MONTHS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241499). 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. DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED UNKNOWN SCREW PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241499) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NO COMPLAINT HISTORY REVIEW COULD BE PERFORMED WITHOUT RELEVANT LOT AND ITEM INFORMATION UNKNOWN ZIMMER SCREW. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    REPORTED SCREW BROKE IN IMPLANT DURING RESTORATION. IMPLANT WAS REMOVED. IT WAS ALSO REPORTED THAT THE IMPLANT FRACTURED DURING THE REMOVAL OF THE FRACTURE SCREW. TOOTH # 30.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862238 DENTAL SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention