BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW
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Model Number 22268A |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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A risk to the patient's health could not be excluded for these specific circumstances, since a screw was placed in the patient's spine in a different position than desired with the brainlab device involved, despite according to the surgeon: the screw not placed as desired (at right t12) was revised in the very same surgery.At the end of the surgery all screws were placed in their correct final positions as intended.The outcome of the surgery was successful as intended.There was no direct (or increased) risk of harm to a critical structure due to the reported problem.There was no actual harm/ negative clinical effect to the patient due to this issue (anesthesia time was prolonged by only 5 minutes).There were no further medical/surgical remedial actions necessary, done or planned for this patient as a result of this issue, nor was prolongation of hospitalization required.According to the results of the brainlab technical investigation and the information provided by the hospital, it can be concluded that the root cause of the misplaced screw at right t12 approximately 3-4 mm inferior to its intended position in the pedicle was a movement of the reference array due to an insufficiently rigid fixation and/or inadvertent forces applied during the procedure.While operating at vertebra level t12 (after placing the right side screw, but prior to placing the left side), the surgeon commented that he was constantly bumping into the patient reference while navigating the non-brainlab tap and screwdriver instruments during preparation and placement of the right t12 screw.A movement of the reference array relative to the bone structure it is fixed to can lead to an inaccurate display of tracked instruments on the registered data set in the navigation software compared to their actual positions on the patient anatomy that cannot be compensated for by the navigation software.Despite acknowledging that the reference array had moved or shifted as a result of him bumping into the array while operating at right t12, the surgeon had continued to prepare and place the right t12 screw while relying on the (now inaccurate) navigation display rather than stopping to verify accuracy before determining whether it was still acceptable to continue using navigation to complete the preparation and placement of the screw at right t12.There is no indication of a systematic error or malfunction of the brainlab device (navigation).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
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Event Description
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A minimally invasive surgery (on (b)(6) 2020) on the spine for thoracic fusion at t8 - t12 (and debulking of a tumor at t10), with planned placement of 8 screws (to address a spinal tumor and fracture at t10), was performed with the aid of the display by the brainlab navigation software spine & trauma 3d 2.6.During the procedure the surgeon: positioned the patient in prone position on the operating room table.Placed the reference clamp carbon and 4-sphere array on the spinous process of t11.Acquired an airo 3d scan with automatic image registration (to match the display of the navigation to the current patient anatomy).Verified accuracy of the registration, judged it as good, and accepted it to proceed.Planned screw trajectories using the brainlab pointer.Prepared the screw path using a navigated non-brainlab tap and inserted the screw using a navigated non-brainlab screwdriver (at right t9, left t9, right t8).Enlarged the incision and reseated retractors, verified accuracy and noted a deviation of 3-4mm at left t8, but judged accuracy as good at t11-t12 (below the fracture at t10).Continued to place screws (following the same procedure as described above) at right t11, left t11, and right t12.Stated that there was no room to work at t12 with the spinous process clamp nearby and that he kept hitting the clamp when navigating the tap and driver.Decided to continue conventionally, removed the patient reference clamp/array and inserted screws at left t8 and left t12 using a c-arm.Decided to replace the screw at right t12 as it was placed 2-3 mm lower in the pedicle than desired.Confirmed correct placement of all screws, proceeded to debulk the tumour at t10, placed rods, and closed the patient.According to the hospital/surgeon: the screw not placed as desired (at right t12) was revised in the very same surgery.At the end of the surgery all screws were placed in their correct final positions as intended.The outcome of the surgery was successful as intended.There was no direct (or increased) risk of harm to a critical structure due to the reported problem.There was no actual harm/ negative clinical effect to the patient due to this issue (anesthesia time was prolonged by only 5 minutes).There were no further medical/surgical remedial actions necessary, done or planned for this patient as a result of this issue, nor was prolongation of hospitalization required.
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