MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. XTRA SILENT NITE; ANTI SNORING NIGHTGUARD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The device was returned, the investigation has been completed and the results are as follows: dhr results.The dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Additionally, erkodent reported no further complaints for this material lot.Lot# e-pro 3.0 -11703 (erkoloc-pro) was manufactured from august 31, 2021 and was assigned an expiration of august 2024.Hardware: slcn 22122 was manufactured from june 2, 2021 and was assigned an expiration of june 2024.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: complaint investigator visually inspected the returned device.The returned parts included both upper and lower trays in a silent nite case.The results were summarized: roughness - the flange was smooth; internal/external aspects were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device was clear and transparent.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu-7322 rev 5.0 (silent nite sleep appliance instructions for (use) provides warning in precautions "do not soak the device in mouthwash; denture cleanser, hot water or alcohol; do not wash the device with soap, toothpaste or mouthwash; do not dry the device with a blow dryer; do not store in direct sunlight".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.Supplier erkodent reviewed the incident details and determined no comment was possible.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The haley test article was thermoformed with layers of erkodent material (erkoloc-pro and erkodur).The test results were listed below and summarized in biocompatibility report for haley sleep device (rpt 9733 rev 1.0).For cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.For skin irritation, there was no erythema and no edema observed on the skin of the animals treated with the test article.For sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.The test article showed nonirritant to the oral mucosa as compared to the control article.The device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.These sections were not completed: weight: the patients weight is not provided when asked.Date of event: this information was not provided when asked.Serial #: is not applicable with the exception of serial number as the device is manufactured by prescription.Is not applicable as the device is manufactured by prescription and not implantable.This is the second of two events for the same patient.See manufacturer report for the remaining complaint : 3011649314-2022-00085.

Event Description

The device was delivered (b)(6) 2022 and was used that evening (sleep test required it).It was used about a week (specific date unknown).The patient complained of redness and soreness overall including the palate.The device was checked for adjustments.The device was not used for a few nights and he got better.With that the patient tried the device once more {specific date unknown) with the same reaction occurring.The device was discontinued (b)(6) 2022.There was treatment rendered.With regards to the device: the device was rinsed with warm water prior to delivery and the patient was instructed to do the same.

• Brand Name: XTRA SILENT NITE
• Type of Device: ANTI SNORING NIGHTGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 15235396
• MDR Text Key: 298006265
• Report Number: 3011649314-2022-00499
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Race: Asian