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

Model Number	A-70701
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
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.The cflex head positioner was received by baxter.Upon inspection, it was determined that the top pivot was not holding and needed adjustment.The top pivot was adjusted and inne cam system was replaced.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 cflex head positioner having an unintended movement were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that cflex polar head positioner joint was not holding correct amount of weight.The device was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: C-FLEX POLAR HEAD POSITNER- DEVICE ONLY
• 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: 21926622
• Report Number: 3010216206-2025-00008
• Device Sequence Number: 8907255
• Product Code: CCX
• UDI-Device Identifier: 00615521002701
• UDI-Public: (01)00615521002701
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: A-70701
• Device Catalogue Number: A-70701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/29/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown