MAUDE Adverse Event Report: Surgical Specialties México, S. de R.L. de C.V. Stratafix Spiral; SXPD1B401

Model Number	SXPD1B40112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction

• Brand Name: Stratafix Spiral
• Common Device Name: SXPD1B401
• 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: joseph scoma ; 2755 canyon boulevard; 1st floor; boulder, CO 80302
• MDR Report Key: 50141449
• Report Number: 3010692967-2026-00043
• Device Sequence Number: 9350015
• Product Code: NEW
• UDI-Device Identifier: 10705031227941
• UDI-Public: 10705031227941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SXPD1B40112
• Device Lot Number: F828LMT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2025
• 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
• Patient Sex: Unknown