MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL , S.R.L DEROYAL; NECK ORTHOSIS

Model Number	14-103A-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A call/complaint was received indicating the "collars cracked under chin" before use.The actual sample was not available for return.Engineering completed testing on sample product and found during the backward bend test the adult collar failed at an average displacement of 7.14mm, and the pediatric collar failed at an average displacement of 3.83mm.Whereas in the forward bend test, both the adult and pediatric collars were 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.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, as a preventive action 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 - august 20, 2018 there have been a total of (b)(4) collars reported to be malfunctioning and (b)(4) units sold for a percentage of (b)(4), of this product 14-103a-00 neck orthosis, semi-rigid.The investigation is complete at this time.We will provide a follow up report if additional information becomes available.
Event or Problem Description
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.

• Brand Name: DEROYAL
• Common Device Name: NECK ORTHOSIS
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL , S.R.L; km 7, autopista joaquin; balaguer, pisano free zone, 18; santiago, ; DR
• MDR Report Key: 7800699
• Report Number: 3006851902-2018-00008
• Device Sequence Number: 2508069
• Product Code: IQK
• UDI-Device Identifier: 00749756760096
• UDI-Public: 0749756760096
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 14-103A-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1