BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UP-ANGLED MICROPITUITARY

    MDR report key: 5013133 · Received August 19, 2015

    Report

    Report Number
    5013133
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 17, 2015
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    HTX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT MICROLUMBAR DISKECTOMY, THE AESCULAP UPGOING MICROPITUITARY WAS INSERTED INTO DISC SPACE AT L5-S1. UPON REMOVAL, IT WAS NOTED THAT THE "UPPER JAW" OF THE MICROPITUITARY WAS MISSING. UNABLE TO LOCATE MISSING PIECE. FLUOROSCOPY WAS PERFORMED TO CONFIRM MISSING JAW NOT IN SURGICAL FIELD OR PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547969 UP-ANGLED MICROPITUITARY RONGEUR HTX AESCULAP IMPLANT SYSTEMS, LLC ML44911

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR NO