MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL SYSTEM; Orthopedic stereotaxic instrument

Model Number 10-0001

Device Problem Use of Device Problem (1670)

Patient Problem Nerve Damage (1979)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2023, 7d surgical was notified that a patient who had undergone a primary spinal fusion procedure and a revision surgery was exhibiting a neurological deficit, specifically a foot drop.The surgeon has commented that he will continue to monitor the patient's symptoms.The 7d surgical system software log for the reported event was provided to 7d surgical for investigation.The results of the software log analysis determined that the system and software performed in accordance with system and software design and performance specifications.The 7d surgical complaint investigation team reviewed the structured light image provided in the software log.From the structured light image, the incision, positioning of the reference frame and anatomy of l4 are visible.Through this visualization, it was confirmed that the reference frame was not fixed to the navigated level (l4).Review of the software log also shows that during the cannulation of right l4, the navigation displayed the navigated pedicle probe in a trajectory with medial pedicle breach, then the tool was levered to be displayed in the pedicle.This is likely due to the l4 vertebrae moving relative to the patient reference device.Since the navigated level was several vertebrae away from the reference clamp, this relative motion can contribute to navigation inaccuracies.Post-operative ct images of l4 show the screw trajectory matched the trajectory of the probe display.The complaint investigation did not identify any malfunctions which may have caused or contributed to the reported event.The root cause of the event was determined to be associated with user error when fixating the patient referring device relative to the navigated vertebrae.Investigation results demonstrated that the 7d surgical patient referencing device (7d surgical stainless steele reference clamp) was not rigidly fixated to the level that was instrumented with navigation.It is important to note that risk of motion of the patient referencing device relative to the patient's anatomy has already been identified, assessed, and mitigated in the 7d surgical system risk management file.The following instructions are provided in the 7d surgical system user manual to mitigate the risk of the reported event: "ensure that the 7d surgical reference frame is rigidly attached and locked to boney anatomy.Navigational accuracy can degrade on vertebra levels that are not rigidly connected to the 7d surgical" no actions or corrective actions have been taken at this time as the device performed in accordance with design and performance specifications.The risk of the event has already been mitigated.

Event Description

The primary spinal fusion surgery took place on oct 25, 2023.The surgeon registered to l4 and confirmed registration accuracy before proceeding to navigate.The navigated pedicle probe was used to cannulate each pedicle and the screws were placed in the cannulation.Four pedicles were cannulated with 7d navigation with no concerns at the time of surgery.The surgeon placed screws on one side and had a secondary surgeon place screws on the contralateral side.Intraoperative x-rays were taken to confirm screw positioning during the procedure.Upon a follow-up postoperative ct, it was noted that the l4 right screw had breached the pedicle medially.The patient required a revision surgery to reposition the screw.The revision surgery was performed without navigation.7d surgical was notified of revision surgery on (b)(6) 2023.On (b)(6) 2023, 7d surgical was notified that the patient was exhibiting a neurological deficit.

• Brand Name: 7D SURGICAL SYSTEM
• Type of Device: Orthopedic stereotaxic instrument
• Manufacturer (Section D): 7D SURGICAL ULC; 60 scarsdale road; unit 118; toronto, ontario M3B 2 R7; CA M3B 2R7
• Manufacturer Contact: daniel ziskind ; 60 scarsdale road; unit 118; toronto, ontario M3B 2-R7 ; CA M3B 2R7
• MDR Report Key: 18210634
• MDR Text Key: 329030353
• Report Number: 3012098629-2023-00001
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-0001
• Device Catalogue Number: 10-0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• 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): Disability