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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since apparently a screw was 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.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

An open spine surgery (revision) was performed on (b)(6) 2020 with the aid of brainlab navigation system spine & trauma 3d 2.6.During the procedure the surgeon: positioned the patient in prone position on the or table.Acquired an intra-operative airo ct scan with automatic image registration to match the display of the navigation to the current patient anatomy.Verified the accuracy of registration in the navigation and accepted the registration to proceed.Placed k-wires with the aid of navigation (using the pedicle access needle).Placed screws.Obtained a verification scan and detected that one screw in l2 was incorrectly placed (through the foramen).Continued the surgery without use of navigation.According to the surgeon, the position of the misplaced screw was corrected in a revision surgery.No negative clinical effect to the patient due to this issue was reported, nor any (further) remedial actions necessary, planned or done.

Event Description

An open spine surgery (revision) was performed on (b)(6) 2020 for k-wire/screw placement in l5-s2 with the aid of the display by the brainlab navigation system spine & trauma 3d 2.6.During the procedure the surgeon: positioned the patient in prone position on the or table.Placed the reference system (x-clamp with 4-sphere reference array) apparently between l2 and l3.Acquired an intra-operative airo ct scan with automatic image registration to match the display of the navigation to the current patient anatomy.Verified the accuracy of registration in the navigation and accepted the registration to proceed.Placed k-wires with the aid of navigation (using the brainlab pedicle access needle).Placed screws.Obtained a verification scan and detected that one screw was placed incorrectly (through the foramen) (it was not reported which screw, but image data suggest the screw in right s1).Continued the surgery without use of navigation.According to the surgeon, the position of the misplaced screw was corrected in a revision surgery.No negative clinical effect to the patient due to this issue was reported, nor any (further) remedial actions necessary, planned or done.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a k-wire was placed in the patient's spine in a different position than desired with the brainlab device involved, despite according to the surgeon, the position of the misplaced screw was corrected in a revision surgery, and no negative clinical effect to the patient due to this issue was reported, nor any (further) remedial actions necessary, planned or done.H6: according to the results of this technical investigation and the partial information available, it can be concluded that a possible root cause for one k-wire being placed not as intended (but more inferior, through the foramen) during a revision surgery performed with the aid of brainlab navigation (and resulting screw likely placed without navigation) is: a movement of the navigation reference array during surgery in relation to the vertebra on which it was attached (between l2 and l3) due to insufficient rigid fixation and/or inadvertent forces applied to the reference array/clamp (by e.G.Surrounding skin/tissue) at the surgery after registration was performed and during the navigation/instrumentation performed between l5 and s2.Array movement would lead to a shift between the navigation display of the image dataset and actual patient anatomy.(note: this specific patient's anatomy appeared not to contain defined spinous processes between l3 and l5, which would be due to the patient's unique anatomy, previous surgery, or steps performed at this surgery prior to when the scans were performed.) apparently this possibly resulting deviation of the navigation display was not recognized by the user before the placement of k-wires/screws with the necessary navigation accuracy verification throughout the procedure.A contributing factor that, to a slight extent, may have contributed to the reported deviation is relative movement of the vertebrae operated on (l5-s2) in relation to the reference system placement (between l2 and l3), when applying forces during the surgery.These relative movements when applying forces during the surgery can lead to a shift between the navigation display of the (pre-placement) image dataset and actual patient anatomy.With the information available, there is no indication of any other factors contributing to the reported deviation of the display of navigation.Brainlab cannot assess all potential factors, due to the missing information required for further investigation, which has not been provided by the customer.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 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: 10073726
• MDR Text Key: 195539108
• Report Number: 8043933-2020-00022
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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: 04/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other