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

Model Number	A-70700
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the c-flex repair kit needed to be replaced.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 technician replaced the c-flex repair kit to resolve the reported event.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of c-flex head positioner not holding 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 c-flex head positioning packag had moved while in the locked position.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: C-FLEX POLAR HEAD POSITIONER
• Common Device Name: C-FLEX HEAD POSITIONING SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24807950
• Report Number: 3006697241-2026-00125
• Device Sequence Number: 9944385
• Product Code: CCX
• UDI-Device Identifier: 00615521002701
• UDI-Public: (01)00615521002701
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: Other
• Device Model Number: A-70700
• Device Catalogue Number: A-70700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/07/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown