MAUDE Adverse Event Report: Mainstay Medical Limited ReActiv8; ReActiv8 System

Model Number	5100 / 8145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: ReActiv8
• Common Device Name: ReActiv8 System
• Manufacturer (Section D): Mainstay Medical Limited; clonmel house, forster way; swords, co. dublin K67F2 K3; EI K67F2K3
• Manufacturer Contact: liza dominguez ; 2159 india street; suite 200; san diego, CA 92101 ; +1(619)206-3331
• MDR Report Key: 50781843
• Report Number: 3021520203-2026-00116
• Device Sequence Number: 10708204
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: 0105391527772064112602191729020121S1042118741
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: Lay User/Patient
• Device Model Number: 5100 / 8145
• Device Catalogue Number: 5100 / 8145
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Race: Black Or African American