DeRoyal 14-103A-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00749756760096), received between May 30, 2018 and Dec 20, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 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? 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 OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185207 ↗
• MalfunctionDec 20, 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? 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 OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184983 ↗
• MalfunctionDec 20, 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? 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 (B)(4)? 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: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184975 ↗
• MalfunctionAug 21, 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? PATIENT/END CONSUMER. 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: COLLARS CRACKED UNDER CHIN. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? COLLAR. 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: N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800699 ↗
• MalfunctionJun 28, 2018Fracture; Fracture

  QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2018. WHEN DID QUALITY ISSUE OCCUR? DURING 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: THE PLASTIC PIECE THAT SITS UNDER THE CHIN HAS SNAPPED IN HALF. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? THE PRODUCT WAS BEING USED POST INJURY. 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: THEY JUST HAD TO REPLACE THE BROKEN COLLAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645704 ↗
• MalfunctionMay 30, 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? PATIENT/END CONSUMER. 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 INJURY. 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: N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553772 ↗