BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERACTIVE PRECISION IO SCAN ADAPTER

    MDR report key: 8143254 · Received December 7, 2018

    Report

    Report Number
    3001617766-2018-00363
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Report Date
    December 7, 2018
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING, LLC
    Product Code
    NDP
    UDI-DI
    10841307123460
    PMA / PMN Number
    872.398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    INTERNAL COMPLAINT- CLAIMS (B)(4) WERE ISSUED FOR PART NUMBER 6534-09PT. THE "INVESITGATION" EXPANDED TO PART NUMBER 6530-09PT. INSPECTION ORDER AND IT WAS FOUND TO HAVE MISSING "FEATURS" AND OUTSIDE OF DIAMETER. LOT CHECK DETERMINED THE ISSUED MACHINED PART NUMBER 6530-81PN-M, LOT NUMBER 100780, WAS USED IN FOUR DIFFERENT FINISHED GOODS LOT NUMBERS, 104151, 106478, 114914 AND 124072. THERE IS NO REMAINING INVENTORY FOR ALL 4 LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983040 INTERACTIVE PRECISION IO SCAN ADAPTER SCAN ADAPTER NDP IMPLANT DIRECT SYBRON MANUFACTURING, LLC 104151, 106478, 114914, 124072 10841307123460

    Patients

    Seq Age Sex Outcome Treatment
    1