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 Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to adverse event: a risk to the patient's health could not be excluded for these specific circumstances, since a screw was placed in the patient's spine in a different position than desired with navigation involved, and a revision surgery was required to correct the misplaced screw.The customer refused to provide any further information to brainlab about this surgery.Therefore, with the available information, brainlab can neither confirm nor exclude if the use of the additional aid of the brainlab navigation might have contributed to the misplaced screw.The customer did not report any negative clinical effect or injury to the patient.Further information from the customer is not forthcoming, thus this brainlab conclusion is considered final.In the unlikely event the customer would provide further information, a follow-up report will be submitted.Adverse event problem: based on the very limited information provided by the surgeon, a comprehensive investigation by brainlab could not be performed, and a root cause ultimately could not be determined for the misplacement of a screw that (as stated by the surgeon) "could have been due to navigation inaccuracy".Brainlab requested the required information for the investigation from the customer but the surgeon declined brainlab's request, severely limiting the scope of the investigation.Therefore, with the available information, brainlab can neither confirm nor exclude if the use of the additional aid of the brainlab navigation might have contributed to the misplaced screw.Based on the general inspection performed by brainlab support, the customer's brainlab hardware and the calibration of the navigation to the non-brainlab 3d fluoroscopic scanner could be excluded as root causes.Additionally, subsequent surgeries using the same device (navigation) have been performed successfully without recurrence of the alleged inaccuracy.Therefore, 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.Usage of device: brainlab intends to reiterate the generally relevant topics regarding the use of the device to this customer.

Event Description

According to the surgeon, a surgery on the spine with placement of pedicle screws was performed with the aid of the display of the (b)(4).After the surgery, the surgeon determined a screw was misplaced and performed a revision surgery to replace the screw.The surgeon alleged the screw misplacement "could have been due to navigation inaccuracy".Despite brainlab's request for further information about the surgery (e.G.Date of surgery, indication for surgery, outcome for patient, specific equipment and workflows used, etc.) the surgeon refused to provide any additional details.There was no report by the customer of any injury or actual harm/negative clinical effect to the patient due to this issue.There was no report the revision surgery could not be completed successfully.There was no report of any further medical/surgical remedial actions having been necessary, done, or planned for this patient due to this issue.There was no report of any prolonged hospitalization.

• 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: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 11939451
• MDR Text Key: 264066530
• Report Number: 8043933-2021-00037
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183605
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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