MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268A

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in and through the patient's spine and the sacroiliac joints in a different position than desired with navigation involved, which required a revision surgery, ultimately resulting in a hardware infection requiring almost 3 weeks prolonged hospitalization of the patient.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.At the current point of time, brainlab can neither confirm nor deny if the use of the aid of navigation contributed to the deviation of the two s2ai screws, solely used to prepare the (untapped) paths to an unknown extend and depth with a non-brainlab probe manually calibrated to the navigation.

Event Description

An open surgery on the spine for decompression and fusion of l2-s1 with l4 interbody placement, with intended placement of 10 pedicle screws plus 2 s2ai screws bilateral through the sacroiliac joints, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2.6.During the procedure the surgeon: attached the navigation reference array on vertebra l2, and performed the initial patient registration to a pre-operative ct scan, acquiring registration points on vertebra s1, to match the display of the navigation to the current patient anatomy.For the two s2ai screws, used the navigated pointer to define the entry points for the non-navigated drill to open the cortical bone, and a non-brainlab probe calibrated to navigation to navigate the creation of the path for the following non-navigated tapping and screw placements.The following placement of the l2-s1 pedicle screws was performed without using the aid of navigation.A post-op ct scan on the next day revealed that the two s2ai screws were placed differently than intended, they were more anteriorly oriented than desired and did not pass through the sacroiliac joints as they should.A revision surgery was scheduled to remove the two s2ai screws only, and took place on (b)(6) 2019.The surgical time was ca.1h with anesthesia time of ca.1.5h for this revision surgery, the removed s2ai screws were not replaced.According to the hospital and surgeon: the patient suffered a hardware infection that is attributable to the revision surgery needed, the revision certainly increased the risk of infection.The patient's hospitalization was prolonged by almost 3 weeks due to the infection (in addition to the 2 days prolong for the revision surgery).The patient has a degree of periprosthetic loosening, i.E.Loosening of the screws placed without aid of navigation at the original surgery.As per the surgeon and hospital, this loosening is not related to the deviating and removed s2ai screws, nor to the use of the navigation at the initial surgery.There are no further patient effects or remedial actions, nor further details thereof, communicated by the hospital.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in and through the patient's spine and the sacroiliac joints in a different position than desired with navigation involved, which required a revision surgery, ultimately resulting in a hardware infection requiring almost 3 weeks prolonged hospitalization of the patient.Brainlab can neither confirm nor deny if the use of the aid of navigation contributed to the deviation of the two s2ai screws, solely used to prepare the (untapped) paths to an unknown extend and depth with a non-brainlab probe manually calibrated to the navigation, i.E.With the information and data retrieved from the surgeon and hospital, brainlab is unable to confirm that this path preparation in the patient's anatomy was as intended and displayed by the navigation.H6: according to the results of the brainlab investigation and the information provided by the surgeon, it can be concluded that the root cause for the deviation of the two s2ai screw placements is a deviation of the non-navigated instruments (non-brainlab tap and screwdriver/screw) not following the prepared navigated path, but deviating e.G.By deflection at the si joint, especially if the navigated path was only prepared with the probe up to the si joint, but not through.To such a deviation of non-navigated instruments, there is no contribution nor influence by the brainlab device (navigation).Nevertheless, with the information and data retrieved from the surgeon and hospital, brainlab is unable to confirm that the navigated path preparation in the patient's anatomy was as intended and displayed by the navigation.If a deviation of the instrument position display would have occurred as a possible contributing factor, this would be attributed to a movement of the navigation reference array, due to possibly not sufficiently rigid fixation and/or inadvertent forces applied to the reference array after the patient registration.In case of potential occurrence at this specific surgery, apparently the resulting deviation of the navigation display was not recognized by the user before path preparation with the necessary accuracy verification throughout the procedure.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.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 9754975
• MDR Text Key: 195939573
• Report Number: 8043933-2020-00013
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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: 71115A
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention