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

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	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A call/complaint was received indicating the "cracked under the chin area".The sample has not been received at this time to be able to complete a thorough investigation.The issue was reported as being identified before actual use of the product.The device history record was reviewed and no issues were found.Inventory was inspected and no issues were found.The root cause was unable to be determined, due to the absence of the sample the investigator could not confirm the reported issue.If a sample is received the complaint will be reopened and updated as necessary.Between, (b)(4) 2016 - (b)(4) 2018 there have been a total of 11 collars reported to be malfunctioning for a percentage of (b)(4) units sold, of this product (b)(4) neck orthosis, semi-rigid.No further information is available 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: 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.
Additional Manufacturer Narrative
Engineering completed testing on the 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 - july 26, 2018 there have been a total of 11 collars reported to be malfunctioning and (b)(4) units sold for a percentage of 0.0007%, 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.

• Brand Name: NECK ORTHOSIS
• Common Device Name: ORTHOSIS, CERVICAL
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL , S.R.L; km 7, autopista joaquin; balaguer, pisano free zone, 18; santiago, ; DR
• MDR Report Key: 7553772
• Report Number: 3006851902-2018-00005
• Device Sequence Number: 2193739
• Product Code: IQK
• UDI-Device Identifier: 00749756760096
• UDI-Public: 0749756760096
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: Health Professional
• Device Model Number: 14-103A-00
• Device Lot Number: 45639676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other