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); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in another position than intended with the brainlab device involved, although: - there is no indication of a systematic error or malfunction of the brainlab device. - corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place. - according to the hospital, the surgery was finished without harm to the patient and final screw placement was acceptable; no further remedial actions (besides revised screw in s1 left) were reported that would have been necessary. According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the screws not placed as intended is a damaged navigated instrument (bent thoracic probe), leading to a discrepancy between the virtual display of navigation and the actual patient anatomy. (details: since the instrument calibration was successfully validated before its use, it is concluded that the probe was bent during preparation of the left pedicle of l5. Bending could occur due to lever forces if the instrument trajectory is adjusted without removing the instrument from the pedicle. ) further contributing factors: - a relative movement of the vertebra l5 in relation to the sacrum that could not be compensated by the navigation system, since the reference array was not placed on the vertebra to be operated on. - potential deviations that occurred during insertion of the screw, which was performed without aid of navigation (using a non-navigated screw driver). There is no indication of a systematic error or malfunction of the brainlab navigation device. Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place. Brainlab intends to: - inform this hospital about the investigation results. - corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

An open spine surgery for stabilization of l5 and s1 was planned to be performed with the aid of the brainlab navigation system spine & trauma 3d 2. 6. During the procedure the surgeon: - attached the navigation reference clamp to l5. - verified and accepted the patient registration (matching of virtual display of preoperative image dataset and actual patient anatomy). - placed screws in l5 left and s1 left with the aid of a navigated probe. - acquired a fluoroscopic image and detected that the screws were not placed as desired. - determined that position of the screw in l5 left was still acceptable, whereas the positon of the screw in s1 left was not (too lateral and close to the corticalis of the vertebrae) - further, realized (by visual inspection) that the used navigated probe was bent - decided to revise the screw in s1 left and to place the screws in l5 right and s1 right without aid of navigation (but using fluoroscopic images). According to the hospital, the surgery was finished without harm to the patient and final screw placement was acceptable; no further remedial actions (besides revised screw in s1 left) were reported that would have been necessary.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: andrea miller ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 6192536
• MDR Text Key: 62905124
• Report Number: 8043933-2016-00042
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22268A
• Device Catalogue Number: 22268A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/21/2016 Patient Sequence Number: 1