BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 8304661 · Received February 5, 2019

    Report

    Report Number
    0002023141-2019-00042
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Report Date
    May 6, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED. UDI: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510(K) NUMBER IS K101880. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DOCTOR REPORTS THAT HE WAS GOING TO USE THE IMPLANT (TSVTWB8) AND WHEN HE OPENED THE PACKAGING THERE WAS ONLY THE COVER SCREW AND THE STICKERS IN THERE. THERE WAS NO IMPLANT AND NO MOUNT. DOCTOR HAD ANOTHER IMPLANT TO USE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101083 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT. DZE ZIMMER DENTAL 63839003

    Patients

    Seq Age Sex Outcome Treatment
    1