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); Calibration Problem (2890); Device Handling Problem (3265)

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

Event Date 09/07/2018

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 in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the pedicle screw placements were clinically acceptable and within the pedicle with the first attempt, only slightly off from the desired location.The deviation of the pedicle screws was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and these were re-placed.The screws were replaced successfully as desired at the final attempt with fluoroscopic guidance at the same surgery.The outcome of this surgery was successful as intended.There was no negative clinical effect to the patient due to this issue, nor due to surgery/anesthesia delay.There were no (other) remedial actions for the patient reported by the surgeon that would have been done or necessary or planned, nor any prolong of hospitalization.According to the results of the brainlab investigation and the information provided by the surgeon, it can be concluded that the main cause for two of the pedicle screw placements deviating slightly from the intended position (despite generally clinically acceptable at this surgery) is a combination of two contributing factors: the non-brainlab c-arm that was used to scan the patient anatomy with automatic image registration for the navigation, was found to be no longer appropriately calibrated for the navigation interface, due to long term use and/or less than ideal handling of the equipment.Relative movement of the vertebra operated on (e.G.L4) in relation to the pelvis the navigation reference array was fixated to, which can occur due to a non-rigid connection of the bones when applying forces to the vertebrae during the surgery.These bone (vertebra) movements relative to the array cannot be recognized by the navigation when displaying instrument positions on the pre-surgery images.Apparently, this has not been recognized with the necessary continued verification of navigation accuracy by the user before the pedicle screw placement.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.This non-brainlab c-arm has been re-calibrated for use with brainlab navigation.

Event Description

A minimally invasive surgery on the spine for an (anterior) lumbar interbody fusion l4-s1, navigation only used for the posterior part of the surgery for intended placement of altogether 4 pedicle screws in vertebrae l4 and l5, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2.6.During the procedure the surgeon: positioned the patient in prone position on the or table.Attached the navigation reference array with schanz pins and 2-pin-fixator to the bony pelvis.Performed an intra-operative c-arm scan, verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-op c-arm scan imported into and used by the navigation).Calibrated a (non-brainlab) screwdriver to the navigation, and placed 4 pedicle screws, 2 each in vertebrae l4 and l5.Performed an intra-operative confirmation c-arm scan and determined that the pedicle screws in l4 deviated slightly from the intended position, whereas fully within the pedicles.Despite the screw position was generally clinically acceptable, decided to replace the pedicle screw for the desired position.Used the intra-operative confirmation c-arm scan for a new registration for navigation, verified and accepted this automatic registration of the anatomy to navigation, and re-placed the 2 pedicle screws on l4.Performed another intra-operative confirmation c-arm scan and determined that the pedicle screw positions in l4 were still not improved as desired.Decided to abandon navigation at this stage of surgery, and re-placed the 2 pedicle screws on l4 with fluoroscopic guidance (c-arm), successfully to the desired position at the same surgery.Concluded the surgery as intended.According to the surgeon: the pedicle screw placements were clinically acceptable and within the pedicle with the first attempt, only slightly off from the desired location.The deviation of the pedicle screws was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and these were re-placed.The screws were replaced successfully as desired at the final attempt with fluoroscopic guidance at the same surgery.The outcome of this surgery was successful as intended.There was no negative clinical effect to the patient due to this issue, nor due to surgery/anesthesia delay.There were no (other) remedial actions for the patient reported by the surgeon that would have been done or necessary or planned, nor any prolong of hospitalization.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 7937441
• MDR Text Key: 123533976
• Report Number: 8043933-2018-00034
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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