BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLANT® PRECISION IO SCAN ADAPTER

    MDR report key: 7787685 · Received August 15, 2018

    Report

    Report Number
    3001617766-2018-00192
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 15, 2018
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    NDP
    UDI-DI
    10841307123934
    PMA / PMN Number
    872.398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HHE REPLANT SCAN ADAPTER (B)(4).

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), THE SCAN BODY SENT TO THE LAB WAS ASSEMBLED INCORRECTLY. THE PLASTIC PORTION OF THE SCAN BODY WAS INCORRECTLY ATTACHED TO THE TITANIUM BASE PORTION OF IT. THE FLAT SIDE OF IT IS NOT WHERE IT SHOULD BE. SO, WHEN IT IS SCANNED, IT DOES NOT LINE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625562 REPLANT® PRECISION IO SCAN ADAPTER SCAN ADAPTER NDP IMPLANT DIRECT SYBRON MANUFACTURING LLC 104539 10841307123934

    Patients

    Seq Age Sex Outcome Treatment
    1