BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 8184983 · Received December 20, 2018

    Report

    Report Number
    3006851902-2018-00012
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 29, 2018
    Report Date
    November 29, 2018
    Manufacturer
    DEROYAL INTERCONTINENTAL , S.R.L
    Product Code
    IQK
    UDI-DI
    00749756760096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CALL/COMPLAINT WAS RECEIVED INDICATING THE COLLAR WAS "CRACKED UNDER CHIN" BEFORE USE AND THERE "WERE" NO INJURY REPORTED. THE SAMPLE HAS NOT BEEN RECEIVED. A WORK ORDER NUMBER WAS PROVIDED AND REVIEWED, NO ISSUES WERE FOUND. THE REPORTED WORK ORDER WAS DETERMINED TO HAVE BEEN MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS. ENGINEERING COMPLETED TESTING ON SAMPLE PRODUCT AND FOUND DURING THE BACKWARD BEND TEST THE ADULT COLLAR FAILED AT AN AVERAGE DISPLACEMENT OF 7.14MM. WHEREAS IN THE FORWARD BEND TEST, THE ADULT COLLAR WAS ABLE TO REACH 10MM OF DISPLACEMENT WITHOUT BREAKING. IN CONCLUSION, THE BRIDGE OF THE COLLARS ARE MOST LIKELY FAILING, WHEN BENT BACKWARDS, AS WAS PERFORMED IN THE BACKWARD BEND TEST. THIS INFORMATION DISPLAYS WHAT WILL HAPPEN IF THE PRODUCT IS USED INCORRECTLY OR HAS EXCESSIVE FORCE APPLIED. THIS DOES NOT DEMONSTRATE WHAT MAY HAPPEN IF THE PRODUCT IS USED AS INTENDED. BASED ON THE TESTING PERFORMED BY THE ENGINEERING DEPARTMENT, THE PRODUCT WILL PERFORM PROPERLY IF USED AS INTENDED AND NO EXCESSIVE FORCE IS APPLIED DURING APPLICATION OR USE. BASED ON THE TESTING COMPLETED AND CONCLUSION REACHED BY ALL CONCERNED DEPARTMENTS, COMMUNICATION WAS SENT OUTLINING PLANS TO MOVE FORWARD WITH A CHANGE TO THE RESIN IN ORDER TO SAFEGUARD AGAINST POSSIBLE MISUSE OR FORCE BEYOND THE BREAKING POINT OF THE MATERIAL DURING UNUSUAL APPLICATION. THIS RESIN CHANGE WAS IMPLEMENTED ON OCTOBER 25, 2018. THE INVESTIGATION IS COMPLETE AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024051 DEROYAL NECK ORTHOSIS IQK DEROYAL INTERCONTINENTAL , S.R.L 14-103A-00 48057516 00749756760096

    Patients

    Seq Age Sex Outcome Treatment
    1