MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. TAP III

Lot Number 1105701071

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.This information was not provided when asked the information was not provided when asked.Date of event was not provided when asked.This information was not provided when asked.Is not applicable with the exception of lot number as the device is manufactured by prescription.Is not applicable as the device is manufactured by prescription and is not implantable.

Event Description

It was reported that the patient had an allergic reaction from a tap3 device.The patient reported the issue to the provider in march.It was reported that the patient had a rash around the lips and tongue that lasted for a week.There is no other information provided.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: no dhr was available for review since the device was fabricated per physician's prescription only.Suppliers (erkodent) reviewed the associated material lots and confirmed no manufacturing deviation or abnormalities.Supplier (airway management) confirmed the metal accessories lot was in compliance.Lot# ep2mm11298 (erkoloc-pro) was manufactured from 5/20/2019 and was assigned with 3 years expiration.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 reviewed the returned parts.The returned parts included an upper and lower tray, a adjustable key and a tap case.The results were summarized below: roughness - the edges of the appliance (both upper/lower) felt smooth.Crack - no crack was found.Delamination - layers were intact and did not appear separated.Discoloration - the color of the tray turned yellowish due to the normal usage.The upper metal plate appeared to be discolored (please see the circle from the attached picture) general cleanliness - very clean and no white deposits or cell debris present with the device.Accessories - metal accessories were inspected.Hook, locking screw, adjustment screw, bite pad and metal plate were intact.No rust or discoloration was discovered from the key.Root cause a root cause for this complaint cannot be explicitly determined.Per "warnings" section from patient instruction booklet sent to the patient, it contains the following statement, "allergic reaction may be encountered in people who are sensitive to nickel or self-curing acrylic." however, it was reported the patient has no known allergies or any pre-existing conditions.Per "homecare instructions" section from patient instruction booklet, it contains the following statement, "each morning after use, thoroughly clean your tap3 appliance using a regular soft toothbrush, cool water and antibacterial liquid soap.Do not use hot water." however, it was unknown how the patient was instructed to clean and maintain the device.Per previous investigations airway management suggested the discoloration appeared from tap hardware may have been due to the combination of poor bonding between hardware and acrylic /plastic.The cavity between hardware and plastic allowed moisture or saliva to enter into wing area during the daily use and caused discoloration.Airway management advised the hardware of tap 3 device (17-4ph) is iron based alloy and subjected to discoloration (foreign material) if it come in contact with moisture for prolonged time in high oxidizing environment.However, the returned device was inspected and confirmed it had perfect bonding and no sign of bubbles, air pockets or any fractures.The discoloration of the device appears to be an expected results from usage and doesn't be related to the reported allergic issue.The device's caution label states that "inspect the tap device prior to each use.If any parts of the device become loose or damage, return to your prescriber.Discontinue use if you observe material separation, material degradation, or damage parts.".Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device 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 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 materials of the tray 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.

• Brand Name: TAP III
• Type of Device: TAP III
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca
• MDR Report Key: 10247775
• MDR Text Key: 198074283
• Report Number: 3011649314-2020-00548
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K062951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1105701071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1