MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. CORUS NAVIGATION ACCESS SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	DX-01-160
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6)-lx disposable broke during use.All pieces were sequestered.All pieces were present and accounted for.Not an implant but a disposable item needed to complete procedure.A second unit was opened to complete procedure.

• Brand Name: CORUS NAVIGATION ACCESS SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 4234 hacienda dr. suite 150; pleasanton CA 94588
• MDR Report Key: 23777703
• Report Number: 23777703
• Device Sequence Number: 9933895
• Product Code: OLO
• UDI-Device Identifier: 00852776006638
• UDI-Public: (01)00852776006638
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2025
• Report Date (Section F): 10/13/2025

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: DX-01-160
• Device Catalogue Number: DX-01-160
• Device Lot Number: NAS15251
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 10/13/2025