MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX? II SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068504110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	10/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an obtryx ii system - curved implanted during a procedure and has since experienced complications, including mesh erosion to surrounding tissue/organs, chronic pelvic pain, pelvic inflammation, dyspareunia, and vaginal bleeding.The patient subsequently the patient underwent a vaginal mesh excision surgery on (b)(6) 2025.The patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm as a result of the implanted device.Additionally, the patient claims that she may have to undergo additional surgery, and may in the future suffer, damages such as, significant pain, severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, medical expenses due to the implantation of the device.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of october 5, 2016, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).The explanting physician is: dr.(b)(6).Block h6: the following imdrf patient code captures the reportable event of: e2006 - captures the reportable event of erosion e2330 - captures the reportable event of chronic pelvic pain e2326 - captures the reportable event of pelvic inflammation e1405 - captures the reportable event of dyspareunia e2308 - captures the reportable event of disfigurement e2401 - captures the reportable event of severe and debilitating injuries e0206 - captures the reportable event of embarrassment and mental pain.The following imdrf impact code captures the reportable events of: f1903 - captures the reportable event of mesh explantation.

• Brand Name: OBTRYX? II SYSTEM - CURVED
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24337868
• Report Number: 2124215-2026-08359
• Device Sequence Number: 9773170
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: (01)08714729839255(17)190728(10)38288
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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: 07/28/2019
• Device Model Number: M0068504110
• Device Catalogue Number: M0068504110
• Device Lot Number: 0000038288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 07/28/2016
• 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
• Patient Sex: Female