MAUDE Adverse Event Report: SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. STRATAFIX SPIRAL; SXPL2B400

Model Number	SXPL2B400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that on (b)(6) 2025 a patient had a seroma post-operatively which was treated successfully and then in (b)(6) 2026 a granuloma formed which was also treated successfully.No additional medical intervention or patient injury reported.
Additional Manufacturer Narrative
The actual device was not available for review.Without receiving sterile devices from the same finish, the ethicon third party evaluation of the needle component, or receiving details regarding the preoperative preparation of the device, tools utilized to grasp the needle component, the size trocar used compared to the size needle on the device, procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.An evaluation of the manufacturing records could not be performed as the required lot number was not provided to complete the evaluation.

• Brand Name: STRATAFIX SPIRAL
• Common Device Name: SXPL2B400
• Manufacturer (Section D): SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.; corredor tijuana-rosarito 2000; no. 24702-b; tijuana, b.c. 22235 ; MX 22235
• Manufacturer Contact: virnalisa cobacha ; 2755 canyon boulevard; 1st floor; boulder, CO 80302
• MDR Report Key: 24916285
• Report Number: 3010692967-2026-00013
• Device Sequence Number: 13211632
• Product Code: GAW
• UDI-Device Identifier: 10705031208209
• UDI-Public: 10705031208209
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: SXPL2B400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown