NECK ORTHOSIS 14-103A-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-29 for NECK ORTHOSIS 14-103A-00 manufactured by Deroyal Industries, Inc..

Event Text Entries

[71233142] The complaint call states that the "collar cracked under chin. " the complaint call did not specify if the collar was broken during application on a patient. The issue was reported as being identified before actual use of the product. The sample was received by qc manager based on picture attached to the call, collar was indeed cracked under chin. Device history record (dhr) of the work order (b)(4) provided with the call and work order subassembly and the set up sheets, were reviewed no discrepancies could be found. This part is molded from polypropylene (pp) resin. Qc manager in conjunction with molding supervisor and molding technician evaluated the pictures attached to the call. While evaluating the section where the cracked occurred, from molding supervisor perspective, this area could be improve by reinforcing it and adding more plastic, this will give more strength and robustness to this area. Ppf0302c molding will be sent to the responsible personnel to make the necessary improvements. A corrective and preventive action report (corp (b)(4)) investigation was performed for similar complaints in 2015. As a result, the polypropylene (pp) resin raw material was changed to improve the elasticity of this part. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). It was confirmed that the work order provided within the call was manufactured after the improvement. Although the breakages are occurring, the amounts of complaints received due to this condition have been reduced. As of 03/22/2017, only 4 complaints that call for this type of failure has been received, for product manufactured after the previous corrective action, was implemented. Although, at this time, a definitive root cause could not be determined after examining all available information (finished good work order, sub-assembly and molding set up sheet). With the conclusion about the meeting held with molding supervisor and his inputs about the cracking issue, a potential root cause could be based on piece design and his experience, this section could allow a weakness that may lead to the whole middle section cracking. As corrective action another improvement will be made to the mold by adding more plastic to the middle section. This will give more strength and robustness to this area. The planned completion dates for this improvement, to be made to the mold, is set to the 16/jun/2017. Between, january 1, 2015 - march 27, 2017, there have been a total of 7 collars reported to be malfunctioning and (b)(4) units sold, of this product 14-103a-00 neck orthosis, semi-rigid. No further information is available at this time. We will provide a follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[71233143] *** quality issue details *** date of occurrence: (b)(6) 2017. 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: collar cracked under chin. How was the quality issue was identified? By visual inspection. How was the product being used? Spinal precaution. 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: none.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006851902-2017-00008
MDR Report Key6443037
Report SourceUSER FACILITY
Date Received2017-03-29
Date of Report2017-02-27
Date of Event2017-02-27
Date Mfgr Received2017-02-27
Date Added to Maude2017-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MELISSA LOGSDON
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626157
Manufacturer G1DEROYAL INTERCONTINENTAL , S.R.L
Manufacturer StreetKM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18
Manufacturer CitySANTIAGO,
Manufacturer CountryDR
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNECK ORTHOSIS
Generic NameORTHOSIS, CERVICAL
Product CodeIQK
Date Received2017-03-29
Returned To Mfg2017-03-08
Model Number14-103A-00
Lot Number42667495
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US 37849


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-29

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