BEUDAMED
    FDA Adverse Event Summary report: N

    HTR-PEKK

    MDR report key: 3959949 · Received June 16, 2014

    Report

    Report Number
    3009582362-2014-00005
    Date Received
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    OXFORD PERFORMANCE MATERIALS
    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

    A REVISION SURGERY WAS PLANNED FOR (B)(6), 2014 DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353163 HTR-PEKK CRANIAL IMPLANT GXN OXFORD PERFORMANCE MATERIALS PK614868 IG3458M-06F001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening