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U.S. Department of Health and Human Services

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

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7D SURGICAL, INC. 7D SURGICAL SYSTEM COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
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.
 
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Brand Name7D SURGICAL SYSTEM
Type of DeviceCOMPUTER-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 Key13122551
MDR Text Key283077371
Report Number3012098629-2021-00002
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
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 Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10-0001-03
Device Catalogue Number10-0001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
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