MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION C-FLEX POLAR HEAD POSITNR; C-FLEX HEAD POSITIONING SYSTEM

Model Number	A-70701
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Baxter received a report stating that cflex polar head positioner was not holding its position, it was slipping.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
The head positioner is designed to position and support the patient¿s head in a variety of surgical procedures including, but not limited to spine surgery.These devices are intended to be used by healthcare professionals within the operating room setting.Upon inspection, baxter field service technician determined that internal parts had developed rust.Three cam systems were replaced by the baxter field service technician.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a unit not holding weight after being locked were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: C-FLEX POLAR HEAD POSITNR
• Common Device Name: C-FLEX HEAD POSITIONING SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23458857
• Report Number: 3010216206-2025-00027
• Device Sequence Number: 9040114
• Product Code: CCX
• UDI-Device Identifier: 00615521002701
• UDI-Public: (01)00615521002701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: Other
• Device Model Number: A-70701
• Device Catalogue Number: A-70701
• Device Lot Number: N/A
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown