BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 12M M HEXAGON

    MDR report key: 12923457 · Received December 3, 2021

    Report

    Report Number
    0002023141-2021-03470
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    August 26, 2021
    Report Date
    June 8, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017474
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510(K): K011245 AND K002188.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A IMPL TAPERED SP 3.7MM 12M M HEXAGON (SPMB12) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED NO SIGNS OF USE AND NOT ATTACHED TO THE BUNDLED MOUNT. SEPARATED UPON RECEIPT AND PACKAGE NOT SEALED. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED IMPLANT AND MOUNT. THEY ENGAGED AND DISENGAGED AS INTENDED, HOWEVER TESTING TO RECREATED THE REPORTED EVENT COULD NOT BE PERFORMED AS THE CONDITIONS OF THE DEVICE WHEN IT ARRIVED WITH THE CUSTOMER CANNOT BE RECREATED. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2019110202). 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2019110202) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DENTAL SURGICAL PROCEDURE HE REALIZED THAT WITHIN THE STERILE PACKAGING, THE IMPLANT WAS NOT TIGHT TO THE MOUNTING DEVICE. THE IMPLANT WAS LOOSE. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

    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
    1824387 IMPL TAPERED SP 3.7MM 12M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPMB12 2019110202 00889024017474

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male