DeRoyal 14-103A-98Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756760102), received between Dec 4, 2018 and Dec 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2018Fracture; Fracture

  QUALITY ISSUE INFORMATION: PRODUCT DETAILS: PRODUCT ID: 14-103A-98 - NECK ORTHOSIS, SEMI-RIGID, LOT/SERIAL #: (B)(4) WARNING - NOT FOUND IN (B)(4), QUANTITY: 1 EA, GTIN: (B)(4), DEROYAL SALES ORDER #: NOT ENTERED. QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2018; WHEN DID QUALITY ISSUE OCCUR? BEFORE USE; WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL; WAS A MEDICAL PROCEDURE INVOLVED? NO; NAME OF MEDICAL PROCEDURE: NOT APPLICABLE; DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE; DETAILED DESCRIPTION OF QUALITY ISSUE: CRACKED UNDER CHIN; HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION; HOW WAS THE PRODUCT BEING USED? NECK BRACE; WAS IT THE INITIAL USE OF THE PRODUCT? YES; WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO; WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO; OUTCOME DETAILS: OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE, PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE, KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED, WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184979 ↗
• MalfunctionDec 4, 2018Fracture; Fracture

  QUALITY ISSUE DETAILS. DATE OF OCCURRENCE: (B)(6) 2018. WHEN DID QUALITY ISSUE OCCUR? BEFORE USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? NOT APPLICABLE. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: THE PRODUCT ARRIVED WITH THE PLASTIC FRAME FOR THE CHIN REST CRACKED. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? STOCK FOR INVENTORY. WAS IT THE INITIAL USE OF THE PRODUCT? YES. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. OUTCOME DETAILS: OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: NA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128245 ↗