BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIOLUCENT SPINE REFERENCE CLAMP

    MDR report key: 1696280 · Received May 19, 2010

    Report

    Report Number
    8043933-2010-00009
    Event Type
    Other
    Date Received
    May 19, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    PMA / PMN Number
    K083310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSP, NO ADVERSE CLINICAL EFFECT OCCURRED FOR THE PT IN QUESTION. ALTHOUGH, THERE HAS BEEN NO PT OR USER INJURY AT THIS HOSP NOR REPORTED BY ANY OTHER HOSP, IT CANNOT BE CONCLUDED IF THE HARDWARE FAILURE ACTUALLY CONTRIBUTED TO THE EVENT. IN THE UNLIKELY CASE, THE HARDWARE FAILURE REMAINS UNDETECTED BY THE USER, A POTENTIAL RISK TO PT HEALTH COULD NOT BE EXCLUDED. CORRECTIVE AND PREVENTIVE ACTIONS: SINCE THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR ANY GENERAL QUALITY OR PERFORMANCE ISSUE OF THE BRAINLAB DEVICE REGARDING THIS SPECIFIC ISSUE, THIS SPECIFIC SITUATION IS TO BE REGARDED AS AN ISOLATED CASE. THERE ARE NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    THE BRAINLAB RADIOLUCENT SPINE REFERENCE CLAMP, THAT WAS USED IN COMBINATION WITH A BRAINLAB IMAGE GUIDED SURGERY SYSTEM, BROKE DURING A SPINE SURGERY. DURING THE SURGERY, THE USER RECOGNIZED THAT THE CLAMP WAS BROKEN AND REPLACED IT WITH ANOTHER BRAINLAB REFERENCE CLAMP. ACCORDING TO THE HOSPITAL, 2 SCREWS HAVE BEEN PLACED WITH A LESS THAN IDEAL ANGLE INTO THE VERTEBRA AND THEIR POSITION HAS BEEN CORRECTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLUCENT SPINE REFERENCE CLAMP IMAGE GUIDED SURGERY INSTRUMENT STEREOT OLO BRAINLAB AG 55756A 1058808001-55756A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other