MAUDE Adverse Event Report: DeRoyal Intercontinental, S.R.L Cervical Collar, XTW, Child, Tot; ORTHOSIS, CERVICAL

Model Number	11271000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "the front piece of the standard c-collar has velcro pieces attached to it with an adhesive.The adhesive is detaching from the collar piece and isn't securely holding the c-spine in place as well as it should.This is happening to multiple c-collars in this patient's room (they are switched out with collar care).This particular patient isn't spontaneously moving, but it could be a significant safety risk for a more mobile child.".
Additional Manufacturer Narrative
A user facility reported, "the front piece of the standard c-collar has velcro pieces attached to it with an adhesive.The adhesive is detaching from the collar piece and isn't securely holding the c-spine in place as well as it should.This is happening to multiple c-collars in this patient's room (they are switched out with collar care).This particular patient isn't spontaneously moving, but it could be a significant safety risk for a more mobile child." deroyal industries, inc.Requested return of the device, but it has not yet been received.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.

• Brand Name: Cervical Collar, XTW, Child, Tot
• Common Device Name: ORTHOSIS, CERVICAL
• Manufacturer (Section D): DeRoyal Intercontinental, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DeRoyal Intercontinental, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; +1(865)362-2106
• MDR Report Key: 50193836
• Report Number: 3004605321-2026-00002
• Device Sequence Number: 21303991
• Product Code: IQK
• UDI-Device Identifier: 00749756553742
• UDI-Public: 00749756553742
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: Health Professional
• Device Model Number: 11271000
• Device Lot Number: 62905091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown