BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTRUMENT ADAPTER, STARLOCK INTERFACE

    MDR report key: 1624766 · Received March 2, 2010

    Report

    Report Number
    8043933-2010-00002
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 3, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K010602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THE HOSPITAL'S REPORT NO NEGATIVE OUTCOME FOR THE PATIENT, A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THIS SPECIFIC CASE. THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE OR WITH THIS SPECIFIC DEVICE FOR THE INTENDED USE. ACCORDINGLY THERE ARE NO REMEDIAL ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    THE BRAINLAB ADAPTER, THAT WAS MOUNTED TO THE SURGEON'S INSTRUMENT TO FIXATE THE REFERENCE ARRAY USED FOR IMAGE GUIDED SURGERY BROKE DURING THE SURGERY AND A PIECE FELL INTO THE PATIENT'S HIP JOINT. THE PIECE WAS FOUND AND REMOVED DURING THE SAME SURGERY, THERE WAS NO NEGATIVE OUTCOME FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT ADAPTER, STARLOCK INTERFACE IMAGE GUIDED SURGERY SYSTEM / INSTRUMENT HAW BRAINLAB AG 55080 NA

    Patients

    Seq Age Sex Outcome Treatment
    1