MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (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); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screws were placed differently than intended, with the brainlab device involved, despite according to the surgeon: - there were no negative effects to the patient during the procedure/after procedure due to this issue.- there are no ongoing/remaining negative clinical effects for this patient post-surgery due to this issue - there were no negative clinical effects to this patient due to prolonged surgery/anesthesia (approximately 90 minutes) - no other remedial actions or additional surgery are necessary, done or planned for this patient for this issue (other than repositioning of screws during this same procedure).According to the results of this technical investigation and the information provided by the hospital, it can be concluded that the root cause of the screws placed differently than intended is that the brainlab reference array was mounted in such a way that it touched the implant construct of the lower spine while the upper spine was disconnected from the lower spine; the two parts of the spine were moving independently of one another.While working on the upper spine, the resulting movement most likely caused the brainlab reference array to be moved.Additionally, the surgeons worked several vertebra away from the vertebra where the brainlab reference array was attached (e.G.Working on t2 with the reference placed at t10); resulting relative movement of the vertebra as compared to the reference array is likely.In such a scenario, each of these causes of reference array movement, whether independent or combined, can lead to a deviation in the navigation display compared to reality.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.

Event Description

Patient presented with a traumatic spine injury and severe fracture of the spine.Patient came into the operating room with a nearly foot long open incision in the lumbar area.A previous lumbar fusion hardware implant construct was present.The procedure goal was to fuse the thoracic spine and stabilize the fracture site by compressing the existing lumbar fusion hardware and connecting it to the newly implanted thoracic fusion hardware.The procedure was planned as being open at the t10,9,8 levels and minimally invasive for the levels above that.The top level being fused was t2.Throughout the procedure, airo scans were performed for navigation and several screws on different levels were placed.-each level was navigated in tandem with dr.(b)(6) placing the screws on the patients' left side and dr.(b)(6) placing the screws on the patients' right side.-the 2nd airo scan revealed that all screws placed by dr.(b)(6) were medial and those placed by dr.(b)(6) were lateral.One level showed two screws placed in error on the same level -per the surgeons, the screws placed via the minimally invasive technique, i.E.8 screws placed on the levels t2-t5 were not ideal.Corrections were done for the placement of the screws in t2 and the removal of the 2nd screw in t4 to the correct level t5 using navigation -the 3rd airo scan revealed that the screws at t2 were now both medial.Navigation was not used for additional correction of the screws at the t2 level.Rods were placed and compression of the 2 fusion constructs was performed.According to the surgeon: - there were no negative effects to the patient during the procedure/after procedure due to this issue.- there are no ongoing/remaining negative clinical effects for this patient post-surgery due to this issue.- there were no negative clinical effects to this patient due to prolonged surgery/anesthesia (approximately 90 minutes).- no other remedial actions or additional surgery are necessary, done or planned for this patient for this issue (other than repositioning of screws during this same procedure).

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer Contact: paul neil ; olof-palme-strasse 9; munich, 81829 ; GM 81829 ; 89 9915680
• MDR Report Key: 6660496
• MDR Text Key: 78188313
• Report Number: 8043933-2017-00016
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070106
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22268A
• Device Catalogue Number: 71116A
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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): Other