MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screw(s) were placed in another location than intended in the spine, with the brainlab device involved, and therewith could have led to harm of the spinal cord and/or blood vessels, and thus in a worst case scenario ultimately to serious harm to the patient, although: the outcome of the revision surgery was successful (surgeon was satisfied with placement of all screws).The hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides revision surgery) that would have been necessary.Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable.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 to the fda upon completion of investigation.

Event Description

A surgery on the spine for l5-s1 posterior fusion was performed with the aid of the brainlab navigation software spine&trauma 3d 2.6 (on (b)(6) 2019).A ct scan was acquired (using the airo), whereby 'supine' was selected instead of 'prone' at the scanner console (airo pendant) by the ct technician.During the procedure the surgeon: verified the accuracy of the patient registration (that matches the display of the ct scan, imported into the navigation, to the current patient anatomy) and accepted the result: placed 4 screws.Obtained a control scan to verify screw placement, and decided to adjust the placement of one screw: verified registration accuracy during the procedure, and was made aware that right and left looked switched and was asked to stop.Was informed that incorrect patient positioning information had been entered at the ct.Scanner: rescanned the patient (with correct patient positioning information).Verified registration accuracy and replaced one screw.Obtained another control scan to verify screw placement and was satisfied with the position of all screws.On the following day ((b)(6) 2019), the surgeon decided to replace one screw (unknown if same screw or other screw) since its position was determined to be slightly too medial.A revision surgery was scheduled for (b)(6) 2019, and the screw was replaced successfully.A control scan was obtained, and the surgeon was satisfied with the location of all screws.The hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides revision surgery) that would have been necessary.

Event Description

A surgery on the spine for l5-s1 posterior fusion was performed with the aid of the brainlab navigation software spine&trauma 3d 2.6 (on may 8, 2019).A ct scan was acquired (using the airo), whereby 'supine' was selected instead of 'prone' at the scanner console (airo pendant) by the ct technician.During the procedure the surgeon: verified the accuracy of the patient registration (that matches the display of the ct scan, imported into the navigation, to the current patient anatomy) and accepted the result.Placed 4 screws with aid of navigation.Obtained a control scan to verify screw placement, decided to adjust the placement of one screw, and began to remove the screw.Was made aware that right/left labeling was switched (due to incorrect information entered at the ct scanner), and inserted the screw back into its original position (had begun to remove right l5 screw, when left l5 screw was intended).Rescanned the patient (with correct patient positioning information).Verified registration accuracy, accepted the result, and replaced the intended screw (left l5).Obtained another control scan to verify screw placement.Based on image data, apparently adjusted the left l5 screw again (unknown if with/out aid of navigation).Was satisfied with the position of all screws.On the following day ((b)(6) 2019), a new ct scan was obtained and the surgeon decided to replace another screw (right l5) since its position was determined to be slightly too medial.A revision surgery was scheduled for (b)(6) 2019, and the screw was replaced successfully with aid of navigation.A control scan was obtained, and the surgeon was satisfied with the location of all screws.According to the hospital/surgeon: the final screw placements are correct (with left l5 screw replaced at same surgery and right l5 screw replaced at revision surgery).However, the patient experienced some right leg pain (pain medication was prescribed, and the patient is monitored closely).Anesthesia time of initial surgery was prolonged 30 min and revision surgery required anesthesia time of 90 min, neither of which led to a negative clinical effect for the patient.Hospitalization was prolonged approx.2 days.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screws were placed in the patient's spine in a different position than desired with the brainlab device involved, and the patient experienced some right leg pain after the surgery and hospitalization was prolonged approx.2 days, although according to the hospital: the final screw placements are correct (with left l5 screw replaced at same surgery and right l5 screw replaced at revision surgery).Anesthesia time of initial surgery was prolonged 30 min and revision surgery required anesthesia time of 90 min, neither of which led to a negative clinical effect for the patient.According to the results of this technical investigation and the information provided by the hospital, it can be concluded that the root cause for the deviation of the screw placements from the intended and planned position can be attributed to a movement of the navigation reference array during the surgery due to a not sufficient rigid fixation.Due to the general anatomy of the patient, the necessary rigidity of the reference could not be achieved for this patient with the attachment on the iliac crest using schanz pins.Details: both schanz pins were not inserted correctly to the bone (instead of a parallel placement the pins almost touched each other at one point) causing an unreliable and therefore flexible mounting.In addition to that, the schanz pins were not inserted deep enough into the bone so that a rigid connection could not be achieved.Due to this and in addition, performing a minimally invasive surgery, it is very likely that the reference moved.E.G.While inserting the screwdriver through the incision and aligning it to the trajectory, the soft tissue could have been pulled/pushed, leading to further reference array movements.The movement of the array is also visible comparing two consecutive surgery scans.Apparently the resulting deviation of the navigation display during the surgery was not recognized by the user before the placement of the pedicle screws with the necessary navigation accuracy verification throughout the procedure.Further, to a lesser extend potentially contributing factor, that may have added to the deviation: the navigated screwdriver was not re-calibrated after each new screw although different screw sizes have been used.That leads to the fact that the real screwdriver length is not represented within the navigation software and can lead to misplacements of the screw.Note regarding the wrong information entered for the scan (supine instead of prone): this error is not expected to lead to screw misplacement since the navigation software is still accurate.The automatic image registration is correct, i.E.Matching of virtual display to actual patient anatomy is correct (only labels a/p and l/r in the software are wrong, corresponding to the wrong information entered at the scanner).A wrong labeling (merely) may confuse the surgeon.In this case, the surgeon started to remove the wrong screw, but before complete removal of the screw, the wrong labeling was recognized and the surgeon was made aware, and the screw was inserted again at the same position as before; subsequently, a new scan was obtained with the correct information entered at the scanner, and the intended screw was replaced successfully.Further, note that the software offers a possibility to correct a possible wrong labeling but apparently the user was not aware of this option or did not use it.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.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 8673685
• MDR Text Key: 147167170
• Report Number: 8043933-2019-00028
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268A
• Device Catalogue Number: 71116A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other