BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 15993156 · Received December 15, 2022

    Report

    Report Number
    0002023141-2022-03147
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 29, 2022
    Report Date
    April 6, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,4.7,10,MTX,MG (TSVTWB10) WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. THE COOB COULD NOT BE VERIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATIONS ARE NOT RELEVANT TO THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PICTURES. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1253642). 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. UPON REVIEW OF THE DHR, PACKAGING IMAGES HAVE BEEN ATTACHED TO FURTHER VERIFY THE CONFORMANCE OF THE PACKAGING FOR THE REPORTED DEVICE. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1253642) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED, AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE CIRCUMSTANCES OF THE DEVICE DELIVERY COULD NOT BE RECREATED. ADDITIONALLY, THE ALLEGED COOB COULD NOT BE VERIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP." H3: CHANGED "YES" TO "NO."

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED:B4: DATE OF THIS REPORT.B5: EVENT DESCRIPTION.G3: DATE RECEIVED BY MANUFACTURER.G6: CHECKED "FOLLOW-UP".H2: CHECKED FOLLOW-UP TYPE.H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE IMPLANT WAS NOT IN ITS PACKAGE. THE CAP WAS SECURE THE STICKS WERE IN THE CONTAINER BUT NO IMPLANT WHEN THE DOCTOR UNSCREWED THE CAP. NO PATIENT IMPACT.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGE WAS DISCARDED BECAUSE THEY DID NOT KNOW TO SEND THE EMPTY PACKAGE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734935 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB10 1253642 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose