MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L CERVICAL COLLAR, EMT SELECT, ONE PIECE, ADULT UNIV; ORTHOSIS, CERVICAL

Model Number	1044-31
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse went to apply the c-collar to a patient and the front neck piece split.
Additional Manufacturer Narrative
A voluntary medwatch report (#mw5151053) was received on 02/20/2024 reporting a nurse went to apply the c-collar to a patient and the front neck piece split.No injury was reported.The sample is being returned to the manufacturing facility for evaluation.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A voluntary medwatch report (#mw5151053) was received on 02/20/2024 reporting a nurse went to apply the c-collar to a patient and the front neck piece split.No injury was reported.The sample was returned and evaluated by the manufacturing facility.Based on the investigation performed and the verification of the physical sample, the root cause was determined to be an operator error.The following corrective actions have been taken by deroyal: retraining was given to injection molding operators to make sure the adult chin cup (part# ppf0302c) are made according to the manufacturing specifications and work order routing and no defective product exit the manufacturing process.Retraining was given to the personnel in charge of manufacture the emt, cervical collars to make sure that the work order procedure (pcd.Qlp.049) is being followed and the product is assembled according to the routing steps and no defective parts are being used.An inventory check of the collar was made by deroyal, a total of 32 of the 1044-31 cervical collar, emt select one piece, adult univ lot # 60385985 and 13 of the ppf0302c extrication collar/adult front lot # 60319531 were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CERVICAL COLLAR, EMT SELECT, ONE PIECE, ADULT UNIV
• Common Device Name: ORTHOSIS, CERVICAL
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 18921816
• Report Number: 3004605321-2024-00001
• Device Sequence Number: 18041975
• Product Code: IQK
• UDI-Device Identifier: 00749756553483
• UDI-Public: 00749756553483
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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
• Device Model Number: 1044-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown