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

Model Number	A-70710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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.Allen c-flex was received by baxter.Upon inspection, it was found that the lower pivot point of the c-flex was not holding position.It was determined that the internal parts of pivot were rusted and needed to be 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 c-flex not holding its position 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 the c-flex will not hold its position.The device was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Correction: new information was provided confirming that the correct model number of the faulty device is a-70710 with serial number (b)(6).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.Allen c-flex was received by baxter.Upon inspection, it was found that the lower pivot point of the c-flex was not holding position.It was determined that the internal parts of pivot were rusted and needed to be 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 c-flex not holding its position 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 the c-flex will not hold its position.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
• 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: 21586843
• Report Number: 3010216206-2025-00003
• Device Sequence Number: 21199077
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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-70710
• Device Catalogue Number: A-70710
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 06/24/2025
• 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