BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORIAN FSP

    MDR report key: 2042156 · Received March 28, 2011

    Report

    Report Number
    8030965-2011-00118
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SYNTHES NORIAN
    Product Code
    MQV
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION HAS NOT BEEN PROVIDED. CANNOT BE DETERMINED WITHOUT A CATALOG NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM JOLIMONT HAINE (B)(6) IN (B)(6) INDICATES THAT A PATIENT UNDERWENT CRANIOPLASTY AFTER REMOVAL OF PART OF THE TEMPORAL BONE. THE DURA WAS NOT OPENED AND PATIENT WAS IMPLANTED WITH (B)(4). PATIENT WAS TREATED WITH RADIOTHERAPY AFTER THE PROCEDURE. TWO MONTHS AFTER THE SURGERY, THE (B)(6) HAD DISAPPEARED AND THE SURGEON COULD SEE THE DURA BEATING THROUGH THE SKIN. REMAINDER OF THE (B)(4) (ONLY CRUMBS AND POWDER) WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORIAN FSP NORIAN FSP MQV SYNTHES NORIAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention