BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 11543678 · Received March 22, 2021

    Report

    Report Number
    0002023141-2021-00694
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 26, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: H10: ADDITIONAL NARRATIVE A IMP,TSV,4.1MM,SBM,11.5 (TSV4B11) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240254). 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. SEE ATTACHED 1240254 PRE STER_1-5 COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240254) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). IMPLANT DATE NOT APPLICABLE. EXPLANT DATE NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT SURGERY, THE DOCTOR NOTICED THAT THE IMPLANT WAS MISSING FROM THE PACKAGING. DOCTOR PLACED ANOTHER IMPLANT OF DIFFERENT SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441745 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1240254 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1