MAUDE Adverse Event Report: AUGMENIX, INC. SPACEOAR SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number	SO-2101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Fibrosis (3167)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e2326 captures the reportable event of inflammation.Imdrf patient code e2313 captures the reportable event of fibrosis.
Event or Problem Description
It was reported that a patient who underwent a spaceoar placement procedure in 2019 developed xanthogranulomatous inflammation in the implanted area in (b)(6) 2025.It was reported that "therapy is no longer on-going" which may indicate that the patient's radiation treatment was interrupted due to the event or had been completed at the time the event developed.The patient needed to be hospitalized and underwent an unspecified intervention.The current patient state of health was unknown.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Device history record (dhr) review was conducted and no deviations that could have contributed to the reported event were found.A labeling review was performed, and the adverse events report are known and documented in the labeling.Risk review was completed and confirmed that the events of "inflammation and fibrosis" were defined in the risk documentation and are documented.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, this investigation is assigned to cause not establish, since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
It was reported that a patient who underwent spaceoar placement procedure, developed a xanthogranulomatous inflammation in the implanted area.It was reported that "therapy is no longer on going" which may indicate that the patient's radiation treatment was interrupted due to the event or had been completed at the time the event developed.The patient needed to be hospitalized and underwent an unspecified intervention.The current patient state of health was unknown.

• Brand Name: SPACEOAR SYSTEM
• Common Device Name: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 500 commander shea boulevard; cork MA 02171
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24645124
• Report Number: 2124215-2026-15354
• Device Sequence Number: 9918456
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: (01)00864661000102(17)200126(10)3051801
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Expiration Date: 01/26/2020
• Device Model Number: SO-2101
• Device Catalogue Number: SO-2101
• Device Lot Number: 0003051801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 03/05/2018
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Race: Black Or African American