Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minim

FDA device recall Z-1469-2014 · posted 2014-04-17 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated

Action taken

Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter included instructions for the modification of C-arm configurations: 1) If possible, Use analog image transfer between C-arm and Brainlab Navigation System and to consult with the local Brainlab Customer Support Representative for this modification, and 2) If possible, adjust the image size of the C-arm to 8 bit and to follow the instructions provided with the C-arm and if required to consult the C-arm manufacturer. For measures when performing a Fluoro match registration, the following instructions are provided to reduce the probability that the algorithm results in an inaccurate match: 1) perform the preoperative CT scans according to the descriptions in the Brainlab scan protocol, 2) set the threshold so that a smooth bone surface is displayed and the quality of the chosen bone threshold influences the accuracy of the match result (refer to section "Bone Threshold" in the Software User Guide"), 3) use the Radiolucent Spine Reference Clamp instead of the Spine Reference X-Clamp, 4) make sure that no additional objects (e.g. wires, retractors, instruments, etc.) are within the view of the C-arm. Additional reminders in the letter include: 1) always verify registration accuracy by holding the pointer or instrument tip to at least three anatomical landmarks and verifying their position in the software, 2) verify that the registration is at the correct level on the patient and data set, and 3) accuracy must be checked on the treated bone surface. Brainlab will provide a software update with the issue solved to affected customers tentatively by January 2014. Customers with questions can contact the Customer Hotline at 800-597-5911 or via e-mail at us.support@brainlab.com.

Root cause

Software design

Status

Terminated

Product code

HAW

Quantity affected

133 units

Distribution

Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Rep

Date initiated

2013-11-18

Date posted

2014-04-17

Date terminated

2017-07-17

Location

Feldkirchen, Germany

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