MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS C-FLEX POLAR HEAD POSITNR- DEVICE ONLY; C-FLEX HEAD POSITIONING SYSTEM

Model Number	A-70701
Medical Device Problem Codes	Positioning Failure (1158); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of a c-flex polar head positioner the device moved and would not hold in place.There was no allegation of injury from the event.It is noted this occurred in the or setting, at the start of a procedure, and there was no indication the device was going to fail.This event was captured under hill-rom complaint ref (b)(4).
Additional Manufacturer Narrative
The c-flex head positioning system can be used in all types of spinal surgery, giving surgeons and anesthesiologists precise control over the head and cervical spine.The ¿squeeze and position¿ technology supports exact set up and readjustments intraoperatively.Versatility is provided by the ability to use the system with headrests or with skull clamps, the quick-connect coupler making connecting to a skull clamp quick and easy.An extensive range of motion makes the c-flex system ideal for use with extremely kyphotic patients, anterior artificial discs and lateral procedures.Follow-up attempts were made with the customer; however, they have not provided any further details of the initial alleged unintended movement associated with the device, including sequence of events, length of delay allegations (if any), and type of anesthesia provided (if any).The device was inspected by the hillrom engineering & repair team.No noticeable issues were observed to be root cause of the device holding failure.The device was taken apart, no internal parts were damaged, device was put back together with all screws & belleville washers put back into place & tightened.The device was retested & did not show any signs of previous issues involving hold force.There was no allegation of injury or confirmed delay with the event.If there are any concerns on functionality, the product would be removed from service or repair and a backup device used.Inspection confirmed no malfunction of the device or its components.If the positioner were to cause head drop of the patient due to the user not correctly locking the device into place (which could not be confirmed) outcomes could vary from causing a brief delay in the procedure to a potential serious injury.Based on the limited information provided on the sequence of events leading to the device not holding appropriately; hillrom is cautiously reporting this event due to the reported (but not confirmed) potential malfunction (positioner not holding in place) being likely to cause or contribute to a serious injury with recurrence.

• Brand Name: C-FLEX POLAR HEAD POSITNR- DEVICE ONLY
• Common Device Name: C-FLEX HEAD POSITIONING SYSTEM
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15508217
• Report Number: 3010216206-2022-00005
• Device Sequence Number: 20294451
• Product Code: CCX
• UDI-Device Identifier: 00615521002701
• UDI-Public: 615521002701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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
• Device Model Number: A-70701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown