BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE PLATING SYSTEM

    MDR report key: 11959740 · Received June 8, 2021

    Report

    Report Number
    3006179046-2021-00298
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 13, 2021
    Report Date
    August 9, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    KTT
    UDI-DI
    00887517021526
    PMA / PMN Number
    K192181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR VISUAL AND FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED CORROSION ON THE PLATE. PER THE REPORTED FAILURE MODE, FUNCTION TESTING WAS NOT APPLICABLE. THE ROOT CAUSE OF THE REPORTED EVENT IS BEING INVESTIGATED UNDER A CAPA AND INVESTIGATION IS STILL ONGOING. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON LOT NUMBER: 0070605 AND THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE FINISHED PRODUCT MET ALL ACCEPTANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION, HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT UPON EXPLANT, THE PLATE WAS NOTED TO HAVE VISIBLE DISCOLORATION AND CORROSION. NO PATIENT ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853292 PRECICE PLATING SYSTEM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT NUVASIVE SPECIALIZED ORTHOPEDICS, INC. LP4.5-PLF4B 0070605 00887517021526

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR