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

Model Number 10-0001-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 12/08/2021

Event Type  Death  

Manufacturer Narrative

A 7d surgical representative visited the site and a complete system performance check was performed, results indicated that the system was operating within normal specifications.Results from the 7d surgical investigation determined that the device did not malfunction.Based on a review of the anonymized navigation log files retrieved from the system there were no issues with the registration, verification or the navigation during the case.A review of the navigation data feed indicated that multiple cannulations were made in the sacrum while attempting to get the proper s2ai trajectory.The most likely root cause of the injury was that when tapping with 8.5mm unnavigated tap that the tap followed a prior cannulation and skived at the si joint and lacerated an iliac artery.It is important to note that the device has been evaluated at the customer site and was found to operate in accordance with performance specifications.

Event Description

7d surgical received information regarding navigation being used in an open t4-pelvis fusion.T4- s1 screws were all placed accurately with the aid of the 7d system.When preparing to place the left s2ai screw the surgeon registered, verified navigation accuracy and cannulated the left s2ai trajectory using the navigated lumbar awl and pedicle probe.Using an unnavigated ball tip feeler, the surgeon checked the cannulation and commented that he felt the floor.The surgeon then used an unnavigated 8.5mm tap to tap the cannulation.However, when the tap was removed the surgical cavity began to fill with blood.The surgeon rechecked the tapped cannulation once the bleeding had slowed and stated he could no longer feel the floor meaning that the tool had breached the bone.The case was stopped, and the patient was taken to interventional radiology.The root cause of the bleeding was due to a laceration of an iliac artery.Unfortunately, the patient subsequently passed away from the injury.Both the surgeon and the hospital consider that there was no causal relationship between the use of the 7d surgical system and the injury.

• 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 road; unit 118; toronto, ontario M3B 2-R7 ; CA M3B 2R7
• MDR Report Key: 13122551
• MDR Text Key: 283077371
• Report Number: 3012098629-2021-00002
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-0001-03
• Device Catalogue Number: 10-0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death