MAUDE Adverse Event Report: GENESYS SPINE SIROS-O; THREADED METALLIC BONE SCREW

Model Number	GSI-SO09540
Medical Device Problem Codes	Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Inadequate Osseointegration (2646); Back pain (4895)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had both of her si joints fused in two separate procedures.One surgery, performed (b)(6) 2025, treated the patient's right side and the second surgery was performed (b)(6) 2025 to treat her left side.Two titanium alloy implants were placed, using an oblique trajectory, in each si joint.The implants are made from medical grade titanium alloy (ti-6al-4v eli).A routine follow-up visit and ct scan was performed in late (b)(6) 2025.The results showed "surgical screw implants in both si joints appear to be adequately positioned".However, the physician reported that no fusion had occurred at that time.If fusion still has not occurred, it could be the cause, or a contributing factor, of the patient's symptoms.Sometime after (b)(6) 2025, the patient began experiencing lower back pain and upper buttock pain around the incision site.She began seeing another pain management physician and she recently had a lumbar radiofrequency ablation performed.This produced very little reduction in her pain.The pain management physician was reportedly doing steroid based injections as well as medication (additional details were not provided).During the patient's last office visit (b)(6) 2026) with the physician that surgically treated her si joints, the patient expressed concern that she may be allergic to the titanium implants.During the visit, an updated mri of the lumbar spine was ordered, and the patient was referred to an allergy specialist.As of (b)(6) 2026, the patient had not had the imaging performed.The patient was scheduled to see the allergy specialist on monday (b)(6) 2026) but no follow up information has been provided.Investigation of the implants / manufacturing lots determined the implants were properly designed and manufactured.No device problem was found.The patient's pain appears to be attributed to either a lack of fusion in one or both si joints, or the patient is allergic to titanium alloy.Based on the current information, this issue is categorized as an adverse event without an identified device or use problem.
Event or Problem Description
The patient had two si joint fusion surgeries: her right side was treated on (b)(6) 2025 and her left side was treated on (b)(6) 2025.During a routine follow up and ct scan, performed (b)(6) 2025, the patient had not fused in either si joint.Sometime thereafter, the patient began experiencing lower back pain and upper buttock pain around the incision site.She began seeing a pain management physician.The pain management physician performed a lumbar radiofrequency ablation which produced minimal reduction in pain.The pain management physician is now doing steroid based injections as well as medication management.

• Brand Name: SIROS-O
• Common Device Name: THREADED METALLIC BONE SCREW
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of tx hwy south; building three, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE; 1250 capital of tx hwy south; building three, ste 600; austin TX 78746
• Manufacturer Contact: william sowers ; 1250 capital of tx hwy south; building three, ste 600; austin, TX 78746 ; 5123817070
• MDR Report Key: 24475287
• Report Number: 3008455034-2026-00001
• Device Sequence Number: 18518269
• Product Code: OUR
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: GSI-SO09540
• Device Lot Number: WS20241113B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GSI-SO09545 LOT # WS20241127A; GSI-SO09550 LOT # WS20240802A
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female