BEUDAMED
    FDA Adverse Event Summary report: N

    HTR-PEKK

    MDR report key: 4992050 · Received August 7, 2015

    Report

    Report Number
    3009582362-2015-00005
    Date Received
    August 7, 2015
    Date of Event
    July 8, 2015
    Report Date
    August 7, 2015
    Manufacturer
    OXFORD PERFORMANCE MATERIALS, INC.
    Product Code
    GXN
    PMA / PMN Number
    K121818
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT WAS REMOVED DUE TO AN INFECTION. THE PT HAD AN INFECTION ON THE SKIN THAT WAS NOT CAUSED BY THE IMPLANT. SHE HAD AN ACTIVE INFECTION PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521048 HTR-PEKK CRANIAL IMPLANT GXN OXFORD PERFORMANCE MATERIALS, INC. PK616157 IG4278M-24F001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention