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 Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Paresis (1998); Movement Disorder (4412)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pilot hole and a k-wire (thus the following pedicle screw) was placed in the patient's spine in a different location than intended with navigation involved, and after the surgery, the patient presented paresis of hip flexion and knee extension left, which required a revision surgery that took place on the same day to address the paresis and correct the placement, although according to the surgeon: the deviation of 1 of the pedicle screws placed with the aid of navigation involved affecting the nerve, was detected with a post-op scan, and a revision surgery was scheduled and took place on the same day of the initial surgery.The final outcome of the revision surgery was successful as intended, with all placements correct at the end of the surgery.The paresis - of hip flexion and knee extension left - of the patient resulting of the initial surgery is reversible (i.E.Not permanent).There was no other harm or negative effect to the patient reported, and there were no further remedial actions for the patient reported done, necessary or planned.There was no surgery or anesthesia prolong at the initial surgery, and no negative effect to the patient as a result of the repeated (revision) surgery/anesthesia of ca.60min.Hospitalization was prolonged by 1 day.H6: according to the results of the brainlab investigation and the limited information provided by the hospital, despite the hospital choosing to not provide the patient navigation data and logfiles of this surgery to brainlab, it can be concluded that the root cause of the screw at left l4 having deviated by ca.9mm from its intended position, is a decalibrated non-brainlab c-arm that was used to acquire the pre-placement patient fluoroscopy scan that was automatically registered to the navigation display and accepted by the user for the procedure.Specifically, as the test scans performed by brainlab after the procedure revealed inaccuracies that matched the reported deviation, it is reasonable to conclude that the scanner became decalibrated before the surgery occurred.A decalibrated c-arm (due to e.G.Improper handling or damage) will result in an inaccurate navigation registration result.An additional factor that likely contributed to the reported inaccuracy is relative movement of the vertebrae (l4) in relation to l2 where the reference was attached during the surgery.The indication of an unstable spine (spondylodiscitis) increases the likelihood of relative bone movement, in addition to the forces required to prepare the bone and to insert the screw.Vertebra movements relative to the navigation reference array during surgery cannot be recognized by the navigation when displaying tracked instrument positions on the pre-surgery patient scan.Apparently the resulting deviation of the navigation display was not recognized by the user with the necessary navigation accuracy verification after the registration scan was performed, throughout the procedure, and while planning and placing the screw at left l4.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.Including: before further use in combination with navigation, the de-calibrated non-brainlab c-arm scanner must be recalibrated by the manufacturer's representative, with corresponding navigation implementation of a new scanner calibration by a brainlab representative.

Event Description

An open surgery on the lumbar spine for fusion of vertebrae l3 and l4 with cage, due to spondylodiscitis, with intended placement of 4 pedicle screws for fixation, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeon: with the patient in prone position, attached the navigation reference array to the spinous process of l2.Acquired a fluoroscopy scan using an intra-operative c-arm with automatic image registration of the current patient anatomy to the navigation, verified and accepted the registration.Prepared the pedicles (pilot holes) with drilling through the navigated drill guide 2.6mm bilateral in l3, and in left l4, and placed k-wires of ca.2mm diameter in these vertebra pilot holes, for the pedicle screws.For right side l4, navigation was not used for pilot hole preparation and k-wire placement, due to a pre-operative defect of this pedicle.Placed the pedicle screws over these k-wires, following them, without directly navigating the screwdriver or screws.Completed the fusion with decompression and cage placement (non-navigated) and the surgery, and closed the patient.After the surgery, the patient presented paresis of hip flexion and knee extension left.A post-operative ct showed a compression of the nerve root l3 left due to the left l4 screw placed with navigation involved, deviating by ca.9mm shifted towards the head from the intended position.A revision surgery was scheduled and took place on the same day, (b)(6) 2021, to address the paresis and correct the placement.The revision surgery was performed without the aid of brainlab navigation and was successful as intended.According to the surgeon, the paresis of the patient is reversible (i.E.Not permanent).According to the surgeon (treating clinician): the deviation of 1 of the pedicle screws placed with the aid of navigation involved affecting the nerve, was detected with a post-op scan, and a revision surgery was scheduled and took place on the same day of the initial surgery.The final outcome of the revision surgery was successful as intended, with all placements correct at the end of the surgery.The paresis of hip flexion and knee extension left of the patient resulting of the initial surgery is reversible (i.E.Not permanent).There was no other harm or negative effect to the patient reported, and there were no further remedial actions for the patient reported done, necessary or planned.There was no surgery or anesthesia prolong at the initial surgery, and no negative effect to the patient as a result of the repeated (revision) surgery/anesthesia of ca.60min.Hospitalization was prolonged by 1 day.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pilot hole and a k-wire (thus the following pedicle screw) was placed in the patient's spine in a different location than intended with navigation involved, and after the surgery, the patient presented paresis of hip flexion and knee extension left, which required a revision surgery that took place on the same day to address the paresis and correct the placement, although according to the surgeon: the deviation of 1 of the pedicle screws placed with the aid of navigation involved affecting the nerve, was detected with a post-op scan, and a revision surgery was scheduled and took place on the same day of the initial surgery.The final outcome of the revision surgery was successful as intended, with all placements correct at the end of the surgery.The paresis - of hip flexion and knee extension left - of the patient resulting of the initial surgery is reversible (i.E.Not permanent).There was no other harm or negative effect to the patient reported, and there were no further remedial actions for the patient reported done, necessary or planned.There was no surgery or anesthesia prolong at the initial surgery, and no negative effect to the patient as a result of the repeated (revision) surgery/anesthesia of ca.60min.Hospitalization was prolonged by 1 day.According to the results of the brainlab investigation and the limited information provided by the hospital, despite the hospital choosing to not provide the patient navigation data and logfiles of this surgery to brainlab, it can be concluded that the root cause of the screw at left l4 having deviated by ca.9mm from its intended position, is a decalibrated non-brainlab c-arm that was used to acquire the pre-placement patient fluoroscopy scan that was automatically registered to the navigation display and accepted by the user for the procedure.Specifically, as the test scans performed by brainlab after the procedure revealed inaccuracies that matched the reported deviation, it is reasonable to conclude that the scanner became decalibrated before the surgery occurred.A decalibrated c-arm (due to e.G.Improper handling or damage) will result in an inaccurate navigation registration result.An additional factor that likely contributed to the reported inaccuracy is relative movement of the vertebrae (l4) in relation to l2 where the reference was attached during the surgery.The indication of an unstable spine (spondylodiscitis) increases the likelihood of relative bone movement, in addition to the forces required to prepare the bone and to insert the screw.Vertebra movements relative to the navigation reference array during surgery cannot be recognized by the navigation when displaying tracked instrument positions on the pre-surgery patient scan.Apparently the resulting deviation of the navigation display was not recognized by the user with the necessary navigation accuracy verification after the registration scan was performed, throughout the procedure, and while planning and placing the screw at left l4.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.Including: before further use in combination with navigation, the de-calibrated non-brainlab c-arm scanner must be recalibrated by the manufacturer's representative, with corresponding navigation implementation of a new scanner calibration by a brainlab representative.

Event Description

An open surgery on the lumbar spine for fusion of vertebrae l3 and l4 with cage, due to spondylodiscitis, with intended placement of 4 pedicle screws for fixation, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure the surgeon: with the patient in prone position, attached the navigation reference array to the spinous process of l2.Acquired a fluoroscopy scan using an intra-operative c-arm with automatic image registration of the current patient anatomy to the navigation, verified and accepted the registration.Prepared the pedicles (pilot holes) with drilling through the navigated drill guide 2.6mm bilateral in l3, and in left l4, and placed k-wires of ca.2mm diameter in these vertebra pilot holes, for the pedicle screws.For right side l4, navigation was not used for pilot hole preparation and k-wire placement, due to a pre-operative defect of this pedicle.Placed the pedicle screws over these k-wires, following them, without directly navigating the screwdriver or screws.Completed the fusion with decompression and cage placement (non-navigated) and the surgery, and closed the patient.After the surgery, the patient presented paresis of hip flexion and knee extension left.A post-operative ct showed a compression of the nerve root l3 left due to the left l4 screw placed with navigation involved, deviating by ca.9mm shifted towards the head from the intended position.A revision surgery was scheduled and took place on the same day, (b)(6) 2021, to address the paresis and correct the placement.The revision surgery was performed without the aid of brainlab navigation and was successful as intended.According to the surgeon, the paresis of the patient is reversible (i.E.Not permanent).According to the surgeon (treating clinician): the deviation of 1 of the pedicle screws placed with the aid of navigation involved affecting the nerve, was detected with a post-op scan, and a revision surgery was scheduled and took place on the same day of the initial surgery.The final outcome of the revision surgery was successful as intended, with all placements correct at the end of the surgery.The paresis of hip flexion and knee extension left of the patient resulting of the initial surgery is reversible (i.E.Not permanent).There was no other harm or negative effect to the patient reported, and there were no further remedial actions for the patient reported done, necessary or planned.There was no surgery or anesthesia prolong at the initial surgery, and no negative effect to the patient as a result of the repeated (revision) surgery/anesthesia of ca.60min.Hospitalization was prolonged by 1 day.

• 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: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 12975116
• MDR Text Key: 286344799
• Report Number: 8043933-2021-00078
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2021

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: 11/25/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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; Required Intervention