MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires and screws placed with the aid of navigation were not placed as intended and therewith could have led to harm of critical structures and/or blood vessels and thus ultimately to a serious injury of the patient, although: according to the surgeon the k-wire and screw placements at the end of surgery were sufficient, the outcome of the surgery was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects for this patient due to this issue.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 minimal invasive spine surgery for screw placement on l3-l5 was planned to be performed with the aid of brainlab navigation system spine & trauma 3d version 2.5.During the procedure the surgeon: attached the navigation reference array to the patient's iliac crest.Performed the initial patient registration (ct-fluoro matching registration) to match the virtual display of preoperative ct scan to the current patient anatomy.Verified the accuracy of registration and, after multiple registration attempts, determined the registration accuracy as appropriate for the procedure.Placed 6 k-wires in vertebra l3-l5 with the aid of navigation, verified the placement and detected that 4 k-wires (in l3 and l5) were placed with a deviation of 5-10 mm in cranial direction from the intended position.Removed and replaced the k-wires.Placed 2 screws in vertebra l3 with the aid of navigation, verified the placement and detected that the screws were placed with a deviation of 5-10 mm from the intended position.Attempted to perform a re-registration, but could not achieve a sufficiently accurate result.Continued the surgery without the aid of navigation, including correction of the screw placement.According to the surgeon the k-wire and screw placements at the end of surgery were sufficient, the outcome of the surgery was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects for this patient due to this issue.

Event Description

A minimal invasive spine surgery for screw placement on l3-l5 was planned to be performed on (b)(6) 2018 with the aid of brainlab navigation system spine & trauma 3d version 2.5.During the procedure the surgeon: positioned the patient in prone orientation and attached the navigation reference to the patient's iliac crest.Performed the initial patient registration (ct-fluoro matching registration) to match the virtual display of preoperative ct and fluoro scans to the current patient anatomy.Verified the accuracy of registration and, after multiple registration attempts, determined the registration accuracy as appropriate for the procedure.Placed 6 k-wires in vertebra l3-l5 with the aid of navigation.Verified the placement (using c-arm) and detected that 4 k-wires (in l3 and l5) were placed with a deviation of 5-10 mm in cranial direction from the intended position.Removed and replaced the k-wires.Placed 2 screws in vertebra l3 with the aid of navigation.Verified the placement (using c-arm) and detected that the screws were placed with a deviation of 5-10 mm from the intended position.Continued the surgery without the aid of navigation (using c-arm), including correction of the screws placed in l3.According to the hospital/surgeon, the k-wire/screw placements at the end of surgery were sufficient, the outcome of the surgery was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects for this patient due to this issue.Also, the issue did not lead to extended hospitalization.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires and screws placed with the aid of navigation were not placed as intended, although: there is no indication of a systematic error or malfunction of the brainlab navigation device, and according brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.According to the hospital, the k-wire/screw placements at the end of surgery were sufficient, the outcome of the surgery was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects for this patient due to this issue.Also, the issue did not lead to extended hospitalization.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 observed deviation of actual k-wire/screw placement from the intended location is: a relative movement of the vertebrae operated on (l3-l5) in relation to the vertebra where the reference array was attached to (iliac crest), which led to a shift between the virtual display of the image dataset and the actual patient anatomy.These vertebra movements relative to the reference array cannot be recognized by the navigation when displaying instrument positions on the pre-surgery images.Apparently at least one of the fluoro images used was not accurate, followed by an inaccurate ct-fluoro match (neither was detected with the verification steps available in the software, due to e.G.Verification being performed on skin level only, not on the bone), which also led to a shift between the virtual display of the image dataset and the actual patient anatomy.Additionally, the method used by the surgeon (navigating the pointer only; the jamshidi needle to insert the k-wires and the screwdriver to insert the screws were not navigated) might have contributed to the issue (to a deviation of the trajectory displayed by the navigation/ pointer and the actual trajectory).Apparently the deviation has not been recognized by the user with the necessary continued verification of accuracy throughout the procedure prior to k-wire/screw placements.There is no indication of a systematic error or malfunction of the brainlab navigation device.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.

Event Description

A minimal invasive spine surgery for screw placement on l4-s1 was planned to be performed on (b)(6) 2018 with the aid of brainlab navigation system spine & trauma 3d version 2.5.This surgery was the 2nd part of a 2 part case, a l4/5 & l5/s1 alif (anterior lumbar interbody fusion) with posterior stabilization.The 1st step was the anterior fusion of both l4/5 and l5/s1.During the procedure the surgeon: - positioned the patient in prone orientation and attached the navigation reference (2 pin fixator with 3 sphere reference array) to the patient's iliac crest; - performed the initial patient registration (ct-fluoro matching registration) to match the virtual display of the preoperative ct and the fluoro scans to the current patient anatomy; - verified the accuracy of registration (by touching the pointer on the skin above the spinous process that was felt for); - was not able to use the jamshidi needle due to visibility issues (which were already experienced during acquisition of fluoro images); - apparently also performed additional registration attempts, but acceptable accuracy could not be achieved ; - decided to abandon aid of navigation (changed the procedure to a mini-open procedure) and placed screws under fluoroscopic guidance.According to the hospital/surgeon, the screw placements at the end of surgery were sufficient, the outcome of the surgery was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects for this patient due to this issue.Also, the issue did not lead to extended hospitalization.

Manufacturer Narrative

B2, h1: there was no risk to the patient's health for these specific circumstances: usage of the system was abandoned before performing critical surgical steps (cannulating pedicles, placing k-wires/screws).There is no indication of a systematic error or malfunction of the brainlab navigation device.According to the hospital, the k-wire/screw placements at the end of surgery were sufficient, the outcome of the surgery was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects for this patient due to this issue.Also, the issue did not lead to extended hospitalization.H6: note that k-wires/screws were not placed with the aid of navigation system but under fluoroscopic guidance.Use of the navigation system was abandoned due to visibility issues before critical surgical steps were performed (before pedicles were cannulated and k-wires/screws were placed).Thus the brainlab device did not contribute to any potential deviation of actual vs.Intended k-wire/screw placement.However, 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 inaccurate registration is: - apparently at least one of the fluoro images used was not accurate, followed by an inaccurate ct-fluoro match (neither was detected due to improper verification), which led to a shift between the virtual display of the image dataset and the actual patient anatomy.Details regarding the visibility issues reported by the user: in general, not being able to detect the reference / instruments by the camera at all does turn off the possibility to navigate.In case the reference array was intermittent visible / not visible or a marker sphere is partially obscured during the acquisition of a fluoro image, there is a chance that the fluoro image is not perfectly accurate.In this case, use of the navigation system was abandoned prior to performing critical surgical steps.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to minimize this (general) anticipated risk as low as reasonably practicable are already in place.H7: brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.Brainlab already updated the software to version spine&trauma 3d 2.6.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• MDR Report Key: 8183476
• MDR Text Key: 131182667
• Report Number: 8043933-2018-00053
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000714
• UDI-Public: 04056481000714
• Combination Product (y/n): N
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268
• Device Catalogue Number: 22268
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other