MAUDE Adverse Event Report: 7D SURGICAL, INC. 7D SURGICAL SYSTEM COMPUTER-ASSISTED SURGICAL DEVICE

Model Number 10-0001

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

The anonymized system log files from the reported case was retrieved by 7d surgical for determining root cause of the event. Based on the analysis of the session logs, it was determined that this event was not caused by a malfunction of the 7d surgical system and is likely attributed to one of two root causes: (1) deflection of the pedicle access kit (pak, pn: mp6001-7d) before or during cannulation or (2) motion of the reference frame relative to the spine. While advancing the pak through the soft tissue for the right l5 cannulation, navigation showed that the trajectory was inferior to the pedicle. Without removing the pak from the tissue, the user redirected the pak to the what appears to be aligned with the pedicle. It is possible that during this redirection, that the shaft of the pak was deflected relative to the marker array of the pak. This would result in the navigation view on the 7d surgical system displaying a different trajectory than the physical position of the tool inside the patient. Accurate navigation of the pak needle requires the user not to apply forces to the pak that would result in bending of the shaft relative to the array. Additionally, the user did not verify registration accuracy between cannulations so it cannot be ruled out that there was motion of the reference frame relative to the spine. The system and software functioned as designed. This was a use error related event.

Event Description

The surgeon performed l4-l5 pedicle screw implantation in the spine using the pedicle access kit (pak, pn: mp6001-7d). The surgeon performed an intraoperative fluoroscopy and noted that the right l5 screw seemed inferior to the target position but deemed it acceptable. The surgeon continued and completed the surgery. The patient complained of pain on (b)(6) 2020. Following a review of the post-operative ct scan, the right side screw of l5 was identified as a concern. However, the surgeon proceeded to remove both the right-side l4 and l5 screws permanently. On (b)(6) 2020 the physician informed 7d surgical that the patient was doing well following the second surgery performed on (b)(6) 2020.

• Brand Name: 7D SURGICAL SYSTEM
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): 7D SURGICAL, INC.; 60 scarsdale rd; unit 118; toronto, M3B 2 R7; CA M3B 2R7
• Manufacturer Contact: daniel ziskind ; 60 scarsdale rd; unit 118; toronto, M3B 2-R7 ; CA M3B 2R7
• MDR Report Key: 9752209
• MDR Text Key: 182765900
• Report Number: 3012098629-2020-00001
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 10-0001
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/25/2020 Patient Sequence Number: 1