BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 8128245 · Received December 4, 2018

    Report

    Report Number
    3006851902-2018-00009
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 9, 2018
    Manufacturer
    DEROYAL INTERCONTINENTAL , S.R.L
    Product Code
    IQK
    UDI-DI
    00749756760102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CALL/COMPLAINT WAS RECEIVED INDICATING THE "PRODUCT ARRIVED WITH THE PLASTIC FRAME FOR THE CHIN REST CRACKED" BEFORE USE. THE WORK ORDER COULD NOT BE REVIEWED BECAUSE THE FINISHED GOOD LOT NUMBER WAS NOT REPORTED. A PICTURE OF THE SAMPLE WAS RECEIVED AND EVALUATED BY THE MANUFACTURING PLANT. ENGINEERING COMPLETED TESTING ON SAMPLE PRODUCT AND FOUND DURING THE BACKWARD BEND TEST THE ADULT COLLAR FAILED AT AN AVERAGE DISPLACEMENT OF 7.14 MM, AND THE PEDIATRIC COLLAR FAILED AT AN AVERAGE DISPLACEMENT OF 3.83 MM. WHEREAS IN THE FORWARD BEND TEST, BOTH THE ADULT AND PEDIATRIC COLLARS WERE ABLE TO REACH 10 MM 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. 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 WILL SERVE TO FURTHER IMPROVE THE PRODUCT. BETWEEN, JANUARY 1, 2016 - DECEMBER 3, 2018 THERE HAVE BEEN A TOTAL OF 1 COLLAR REPORTED TO BE MALFUNCTIONING AND (B)(4) UNITS SOLD FOR A PERCENTAGE OF (B)(4)%, OF THIS PRODUCT 14-103A-98 NECK ORTHOSIS, SEMI-RIGID. 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? 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968078 DEROYAL NECK ORTHOSIS IQK DEROYAL INTERCONTINENTAL , S.R.L 14-103A-98 00749756760102

    Patients

    Seq Age Sex Outcome Treatment
    1