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BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
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| Model Number 22268-01C |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Paresis (1998); Hypoesthesia (2352); Peripheral Nervous Injury (4414)
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| Event Date 02/10/2022 |
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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 apparently there were problems with the brainlab device resulting in a prolongation of surgery of 40-80 minutes (during total surgical anesthesia time of 9h45m), and this prolongation of surgery contributed to an injury of the patient from the length of time in the prone surgical position - a unilateral (brachial) plexus injury (on the left side) s14.3 according to icd-10, and/or nerve root injury t81.2, which required (or will require) remedial medical actions, specifically rehabilitation and neurophysiological examination, and this injury is only "somewhat reversible" per the surgeon, despite: the outcome of the surgery was successful; all screws were successfully placed to their intended positions.There was no inaccuracy of navigation; all screws and k-wires placed with navigation were correctly placed.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report upon completion of investigation.
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Event Description
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A spine surgery for a corpectomy at l1, fusion of th8-l4 (with planned pedicle screw placements using with the aid of brainlab spine & trauma 3d navigation sw 1.5), and placement of an intracorporal device th12-l2, for a patient with a post-fracture deformity at th11-l1, has been performed.According to the surgeon (treating clinician): various problems with the brainlab software and associated equipment during the surgery, mostly related to visibility of instruments by the camera (based on preliminary information), led to a prolongation of the surgery by approximately 40-80min.This delay, caused by the brainlab device(s), contributed to an injury of the patient (positioned prone for the surgery with a total surgical time of 8:15 - 18:00 or 9h45m): a unilateral (brachial) plexus injury (on the left side) s14.3 according to icd-10, and/or nerve root injury t81.2, which required or will require medical remedial action specifically rehabilitation and neurophysiological examination.The patient's injury is only "somewhat reversible" per the surgeon.The outcome of the surgery was successful; all screws were successfully placed to their intended positions.There was no inaccuracy of navigation; all screws and k-wires placed with the aid of navigation were correctly placed.
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Event Description
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A spine surgery for a corpectomy at l1, fusion of t8-l4 (with planned placement of 16 pedicle screws bilaterally), and placement of an intracorporal device t12-l2, for a patient with a post-fracture deformity at t11-l1, has been performed with the aid of the brainlab spine & trauma 3d navigation sw 1.5.During the procedure the surgeon: - positioned the patient prone on the or table, and positioned the navigation camera at the foot of the or table.- performed the initial incision and exposure, and attached the navigation reference at the patient's lower thoracic region (to the spinous process of either t10 or t11).- acquired a fluoroscopy scan using an intra-operative c-arm intending to additionally obtain automatic image registration of the current patient anatomy to the navigation, however the wrong selection was made at the scanner by the user and no registration was stored.A second scan was acquired with the correct selection to obtain the automatic registration, and this registration was verified and accepted to proceed.The user also initially may have had difficulties positioning the navigation camera such that the reference array and registration matrix were both visible, and had to adjust the camera position, prior to acquiring the scan.- calibrated the brainlab drill guide to the navigation and verified and accepted it to proceed.The surgeon alleged he experienced difficulties initially calibrating the drill guide, however the brainlab logfiles showed the calibration took less than 2 minutes, which is not considered unusual for careful calibration and accuracy verification.- attempted to calibrate a non-brainlab screwdriver to the navigation several times, but was unable to achieve a successful calibration and continued without using navigation for this instrument.The brainlab logfiles showed these initial calibration attempts did not exceed 4 minutes, which is not considered unusual.- used the navigated drill guide to create paths for the 8 intended pedicle screws on the patient's left side, placed k-wires down the paths, and used the non-navigated screwdriver to place cannulated screws over the k-wires into the pedicles.- experienced problems of the navigation camera not being able to track the navigated drill guide consistently during the surgery, with the brainlab navigation software ceasing the display of navigation whenever the camera intermittently lost visibility of the instrument's reference array, as it moved in and out of the camera's line of sight, or crossed with other reference array geometry.The surgeon attempted to reposition the navigation camera for better visibility of the navigated instrument.- attempted to calibrate the third party screwdriver to the navigation again, this time achieving a successful calibration after two attempts (less than 2 minutes spent in the instrument calibration workflow in the navigation software, which is not unusual).- placed 7 screws in the right pedicles as intended, using the same workflow as before, but potentially using the navigated non-brainlab screwdriver to place one or more of these screws.- attempted to use the navigated instruments to place the 8th pedicle screw on the patient's right side, but the reference arrays on the navigated instruments were too close to the patient reference array attached to the spinous process in the patient's lower thoracic region, which resulted in the brainlab navigation software ceasing the display of navigation, when the camera was unable to clearly detect the distinct array geometries of the different reference arrays.Therefore, the surgeon placed this final screw conventionally and without using navigation.- performed a confirmation fluoroscopy scan which confirmed that all screws were correctly placed to their intended positions.- completed the surgery.After the surgery, the patient presented with a total loss of motor function bilaterally in the arms with partial regression on the right side directly during the postop care period.According to the surgeon, the disability was pronounced with an inability to handle objects, handle the phone, bring the hand to the mouth, and the patient also experienced a sensory partial numbness ulnar left, but also right.According to the surgeon, a month postop, there has been a partial regression but there is still significant bilateral weakness, more at the left side, at such a level that the patient cannot eat herself, comb herself, take care of hygiene.In summary, the patient's injury was assessed by the surgeon as: -partial sensory dysfunction, partial regression, -severe paresis, partially reversible, which was coded as a unilateral (brachial) plexus injury (on the left side) s14.3 according to icd-10, and/or nerve root injury t81.2.The patient required rehabilitation and a neurophysiological examination.According to the surgeon (treating clinician): - the problems the user experienced with the brainlab equipment during the surgery, mostly related to visibility of instruments by the camera, led to a prolongation of the surgery by approximately 40-80min (as estimated by the surgeon).- this prolongation, caused by the brainlab navigation device, contributed to an injury of the patient (positioned prone for the surgery with a total surgical time of 8:15 - 18:00 or 9h45m): a unilateral (brachial) plexus injury (on the left side) s14.3 according to icd-10, and/or nerve root injury t81.2, resulting in a total loss of motor function bilaterally in the patient's arms directly postop with partial regression on the right side, and also sensory partial numbness bilaterally, which required medical remedial action specifically rehabilitation and neurophysiological examination.One month post-operatively, the injury is partially regressed/reversible but is still present and interferes with the patient's daily functions.- the outcome of the surgery was successful; all screws were successfully placed to their intended positions.- there was no inaccuracy of navigation; all screws and k-wires placed with navigation were correctly placed.
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Manufacturer Narrative
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B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since the problems the customer experienced with the brainlab device allegedly led to a prolongation of surgery of 40-80min (during total surgical anesthesia time of 9h45m), which cannot be excluded as a contributing factor to the patient's serious injury/deterioration of health from the length of time in the prone surgical position, despite according to the surgeon: - the outcome of the surgery was successful; all screws were successfully placed to their intended positions.- there was no inaccuracy of navigation; all screws and k-wires placed with navigation were correctly placed.H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the intermittent problems the user experienced in the camera tracking the instruments (and subsequent potential prolongation of this specific spine surgery) was a less than ideal operating room setup by the user and handling of the instruments used with navigation.Specifically, with the user attaching the reference on t10/t11 and positioning the navigation camera at the foot of the bed, visibility of the reference would be limited while instrumentation was performed from t12-l4 (also acknowledged by the user that one screw was placed without navigation due to this factor e.G.Overlapping of marker spheres from the instrument/reference arrays due to close proximity while navigating) and could also explain the reported delays in calibrating the non-brainlab screwdriver.There is no indication in the provided log files or testing performed on-site of any performance issues with the brainlab device (including its camera/tracking service and spine & trauma navigation software) nor accuracy/calibration issues with the instruments used for this procedure.Apparently the less than ideal operating room setup was not recognized by the user by carefully considering the room setup before starting the procedure, including placement of the navigation camera, reference array, and operating area for instruments.Regarding the patient's injury: the surgeon has alleged the prolongation of 40-80 minutes (in context of the full length of surgical anesthesia time of 9h45m) from the problems the surgeon experienced with the brainlab device contributed to the patient's injury.In general, the risk and/or harm to the patient when exposed to longer surgical/anesthesia duration is very much dependent on the patient, the type of the surgery (including positioning), and the planned length of the surgery.Thus, the amount of contribution by the extra 40-80 minutes from the use problems of the brainlab device may not have been as clinically significant as other factors, but also this cannot be fully assessed based on the unknown variables of the patient's general health/condition and positioning, and therefore the use of the brainlab device also cannot be excluded as a contributing factor.Thus, the technical root cause for the problems the user experienced with the device is confirmed (as written above), however, the clinical root cause of the patient's injury cannot be fully assessed or confirmed by brainlab.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.H7: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.
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