MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268-01C

Device Problem Use of Device Problem (1670)

Patient Problem Headache (1880)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a dura tear occurred at t3 with navigation involved, although according to the surgeon: -the dura tear at t3 was detected immediately after it occurred, and was successfully repaired at the very same surgery.According to the operating surgeon, the patient was not at risk of serious injury (e.G.Permanent damage to a body structure and/or permanent impairment to a body function), due to the dura tear, if not repaired.-there was no direct or increased risk of harm to a critical structure (e.G.Spinal cord, nerves, blood vessels, etc.) due to the reported problem.-the patient experienced headaches post-operatively from the dura tear, and spent 2 additional days in the hospital, but the headaches were reversible and the patient was discharged.-there were no other remedial actions for the patient done, necessary or planned.-the outcome of the surgery was successful as intended with all screws placed correctly as intended.-there were no negative effects to the patient due to prolonged anesthesia (of ca.30min).H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the deviation in the display of navigation at left t3 compared to the patient's anatomy, leading to a dura tear at left t3 during an invasive surgical step performed with the aid of navigation was most likely a movement of the reference array due to an insufficiently rigid fixation and/or inadvertently applied forces (e.G.Bumping).Any movement of the reference array after registration is performed disrupts the coordinate system established during registration and can result in a deviation of the registered preoperative image, on which tracked instruments are displayed, from the actual patient anatomy, which cannot be compensated by navigation.A potential contributing factor was a registration result accepted by the user that was not as accurate as desired for this surgery, as a possible rotational error in the accepted registration could not be excluded based on review of the restored registration matches.A rotational error in the registration match would result in a deviation in the display of navigation compared to the patient anatomy which increases at larger distances from the vertebra on which the registration was performed (i.E.A larger inaccuracy at t3 compared to t4 where registration points were acquired).Apparently, the resulting deviation in the navigation was not detected by the user with the appropriate and necessary verification checks - especially considering the small pedicle size and therefore small margin of error at left t3 - after the final registration (at the verification step) and/or prior to (or during) navigation of the drill guide at left t3.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.

Event Description

A surgery on the spine for a t2-t11 fusion procedure indicated for scoliosis was performed with the aid of the display by the brainlab spine & trauma 3d navigation software 1.5.Two ct scans were taken 14 days prior to the procedure to be used for screw planning and with navigation.During the procedure the surgeon: - positioned the patient in prone position on the or table.- attached the navigation patient reference array at t11 or t12 and performed, verified, and accepted an initial registration on the pre-op ct at t8, by acquiring registration points on the surface of the vertebra to match the display of the navigation to the current patient anatomy.A navigated drill guide was used to create channels for pedicle screws which were placed at t8-t11.- moved the reference array to t8, and repeated this procedure with a new registration at t5, to place screws from t5-t7.- repositioned the reference array to t5 and performed another registration in the same manner as before, and placed pedicle screws at t4.- verified accuracy at t3 with the navigated pointer and used the navigated drill guide to drill a channel into the pedicle at left t3.- used a probe to feel the walls of the prepared channel at left t3 and discovered the dura had been torn.- repaired the dura tear and completed the rest of the procedure successfully without further use of navigation, using conventional methods.According to the surgeon: -the dura tear at t3 was detected immediately after it occurred, and was successfully repaired at the very same surgery.According to the operating surgeon, the patient was not at risk of serious injury (e.G.Permanent damage to a body structure and/or permanent impairment to a body function), due to the dura tear, if not repaired.-there was no direct or increased risk of harm to a critical structure (e.G.Spinal cord, nerves, blood vessels, etc.) due to the reported problem.-the patient experienced headaches post-operatively from the dura tear, and spent 2 additional days in the hospital, but the headaches were reversible and the patient was discharged.-there were no other remedial actions for the patient done, necessary or planned.-the outcome of the surgery was successful as intended with all screws placed correctly as intended.-there were no negative effects to the patient due to the prolonged anesthesia (of ca.30min).

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 11006995
• MDR Text Key: 226334923
• Report Number: 8043933-2020-00066
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268-01C
• Device Catalogue Number: 22268-01C
• Device Lot Number: SW V. 1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other