MAUDE Adverse Event Report: GENESYS SPINE SIROS; DILATOR

Model Number	GSI206-03
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical technique outlines the implants be delivered through a drill guide but the surgeon placed the implants through a dilator.
Event or Problem Description
During a lateral si fusion procedure, the working channel began filling with blood after placement of the second si screw.The bleed was difficult to control and the patient lost approximately 750cc of blood.Once the bleed was controlled the patient was transferred by ambulance to a hospital.While at the hospital, a neurosurgeon confirmed the si screws were properly placed.The patient was released the next day.

• Brand Name: SIROS
• Common Device Name: DILATOR
• Manufacturer (Section D): GENESYS SPINE; 1250 capitol of tx hwy south; building three, ste 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE
• Manufacturer Contact: william sowers ; 1250 capitol of tx hwy south; building three, ste 600; austin, TX 78746 ; 9545578288
• MDR Report Key: 23068993
• Report Number: 3008455034-2025-00002
• Device Sequence Number: 21252846
• Product Code: OUR
• UDI-Device Identifier: M719GSI206030
• UDI-Public: +M719GSI206030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: GSI206-03
• Device Catalogue Number: GSI206-03
• Device Lot Number: AM20221103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GSI-SD09540, 9.5MM X 40MM SI DUAL THREAD IMPLANT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male