DeRoyal 11271000Recalls & reported problems
Deroyal Industries, Inc. · XTW CERVICAL COLLAR · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756553742), received between Aug 10, 2026 and Aug 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2026Unintended Movement
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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193836 ↗
Other Orthosis, cervical devices
- DeRoyal 14-103A-00Deroyal Industries, Inc. · Orthosis, cervical6 reports
- DeRoyal 1044-31Deroyal Industries, Inc. · Orthosis, cervical2 reports
- DeRoyal 14-103A-98Deroyal Industries, Inc. · Orthosis, cervical2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.