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 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screws were placed minimally invasive in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: - the surgeon realized at the surgery that 2 of the pedicle screws were placed other than intended, confirmed with intra-op ct after placements.- the outcome of the surgery was acceptable.- a 6 of the 8 screws were placed in acceptable locations at first attempt, the positions of the two deviating screws did not have to be revised.There is also no revision surgery necessary.- there were no negative effects to the patient, neither due to pedicle screw placements nor due to surgery/anesthesia prolong (of ca.30min).- there were no other remedial actions necessary, done or planned for this patient (except a post-operative upright x-ray may be planned for the future).- hospitalization was not prolonged either for this patient.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main cause for the deviating pedicle screws is a combination of the following factors: - relative movement of the vertebrae t4 and t7 during the surgery at the screw placements in relation to the reference array mounted at t9.These bone movements relative to the navigation reference cannot be recognized by the navigation.Especially for the 2nd placement with pre-existing holes, same bone movements are likely.- not sufficiently rigid fixation of the reference array at t9, also being subject to forces by soft tissue movements affecting its position during the surgery.- less than ideal calibration of the (non-brainlab) screwdriver with screw to navigation at the surgery, including choosing a too large calibration receptacle diameter for the screw used, and without performing a re-calibration for each new screw diameter used as required.Additionally, movement of the screws at the joint of the navigated (non-brainlab) screwdriver during the screw placements might have occurred.Apparently, this has not been recognized with the necessary continued verification of navigation accuracy by the user before the pedicle screw placements.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

A hybrid -minimally invasive and open- surgery on the spine for a posterior fusion of vertebrae t4-t8 (8 pedicle screws intended, with cage at t6 and 2 connection rods), was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2.6.During the procedure the surgeons: - positioned the patient in prone position on the or table.- attached the navigation reference array on t9.- verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative ct scan imported into and used by the navigation).Breathing was not halted during the scan.- calibrated a (non-brainlab) jamshidi needle to the navigation to determine the pedicle positions.- calibrated a (non-brainlab) screwdriver to the navigation, and placed pedicle screws minimally invasive on t4, t5 and t8 left and right.- decompressed at t6, then placed the pedicle screws on t7 left and right with the navigated screwdriver.- performed an intra-operative confirmation ct scan after also the rods and cage were placed, and determined that 2 of the pedicle screws were not placed as desired: the left t4 screw deviated by ca.5mm towards the head and into the disc space, the right t7 screw with acceptable entry point was angled ca.30 degrees lateral from the intended positions.- verified and accepted the automatic registration of the current patient anatomy to this intra-operative confirmation ct scan to the navigation, and attempted to correct the positions of these 2 screws at the very same surgery, using the navigated (non-brainlab) screwdriver.- performed another intra-operative confirmation ct scan, and determined that the positions of the 2 screws were at the identical position as before, i.E.Fell back in the existing pedicle holes.- finalized the surgery and closed the patient.According to the surgeon: - the surgeon realized at the surgery that 2 of the pedicle screws were placed other than intended, confirmed with intra-op ct after placements.- the outcome of the surgery was acceptable.- a 6 of the 8 screws were placed in acceptable locations at first attempt, the positions of the two deviating screws did not have to be revised.There is also no revision surgery necessary.- there were no negative effects to the patient, neither due to pedicle screw placements nor due to surgery/anesthesia prolong (of ca.30min).- there were no other remedial actions necessary, done or planned for this patient (except a post-operative upright x-ray may be planned for the future).- hospitalization was not prolonged either for this patient.

• 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; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 7391355
• MDR Text Key: 104538884
• Report Number: 8043933-2018-00009
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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