BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM STERILE TUBE DRAPE - 20 PACK

    MDR report key: 1960982 · Received January 11, 2011

    Report

    Report Number
    1723170-2011-00026
    Event Type
    Injury
    Date Received
    January 11, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    KKX
    PMA / PMN Number
    K050996
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE PATIENT DEMOGRAPHIC INFORMATION. CORRECTION TO ACTUAL EVENT DATE.

    Additional Manufacturer Narrative · 1

    INCORRECT PATIENT INFORMATION WAS REPORTED ON FOLLOW UP REPORT #1. CORRECT INFORMATION NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    AS REPORTED, DRAPE RIPPED COMPROMISING STERILE FIELD. SUBSEQUENT TO SURGERY, PATIENT DEVELOPED AN INFECTION OF UNDETERMINED ORIGIN.

    Description of Event or Problem · 1

    SURGEON REPORTED THERE WAS A PROBLEM WITH THE O-ARM DRAPE RIPPING DURING A CERVICAL PROCEDURE, THEREFORE, COMPROMISING THE STERILE FIELD. PATIENT REPORTED TO HAVE DEVELOPED AN INFECTION SUBSEQUENT TO THIS PROCEDURE.

    Additional Manufacturer Narrative · 2

    AS REPORTED, DRAPE RIPPED COMPROMISING STERILE FIELD. SUBSEQUENT TO SURGERY PATIENT DEVELOPED AN INFECTION OF UNDETERMINED ORIGIN.

    Description of Event or Problem · 2

    SURGEON REPORTED THERE WAS A PROBLEM WITH THE O-ARM DRAPE RIPPING DURING A CERVICAL PROCEDURE, THEREFORE, COMPROMISING THE STERILE FIELD. PATIENT REPORTED TO HAVE DEVELOPED AN INFECTION SUBSEQUENT TO THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM STERILE TUBE DRAPE - 20 PACK DRAPE, SURGICAL (KKX) KKX MEDTRONIC NAVIGATION, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention
    2