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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

It was reported that the patient had a reaction to the tapiii device.It was reported that the patient experienced "numbing on the lips, and the tongue.The device was used from (b)(6) 2021 to (b)(6) 2021.It is unclear when the reaction occurred or resolved.The patient has no allergies noted.There is a history of hypertension taking lisnopril/hctz.With regards to the device: the device was rinsed with warm water and a mild soap prior to the delivery of the device.The patient was instructed to the do the same with regards to the care of the device.However, the patient recently used warm water, baking soda and mild dish soap.

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.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 three implant complaints, see manufacturer report for the remaining complaint : 3011649314-2021-00376, 3011649314-2021-00469.

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's (erkodent & airway management) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Additionally, erkodent reported no further complaints for this material lot.Erkodent review: lot# erkodur 2.0-11581 (erkodur) was manufactured from february 22, 2021 and was assigned an expiration of february 2024.Lot# e-pro 2.0-11584 (erkoloc-pro) was manufactured from march 4, 2021 and was assigned an expiration of march 2024.Airway management review: part #: 12k-0qrf-21 was manufactured on 06/03/2021 and no expiration date was noted.Kit #: pkt12k-0qzt-21 was manufactured on 06/03/2021 and no expiration date was noted.Supplier (airway management) reviewed c of c (certificate of conformance), a chemical analysis report, and confirmed material compositions are within specification.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 tap case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device appeared 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.Airway management confirmed the tapiii has nickel content (3-5%) and is very possible to develop an allergic reaction in people with existing sensitivity.However, it was unknown and not reported if the patient was allergic to nickel.Per the reported information, the device was rinsed with warm water and a mild soap prior to the delivery of the device.Additionally, the patient was instructed to the do the same with regards to the care of the device.However, the patient recently used warm water, baking soda and mild dish soap.Per tap3 patient instruction_prtd17 rev.I, the "home care instructions" section states the following: "each morning after use, thoroughly clean your tap¿ 3 appliance using a regular soft toothbrush, cool water and toothpaste.The tap¿ 3 should be stored in a cool dry place.The appliance is made from sensitive materials and should not be stored where temperatures exceed 120of, such as in the glove compartment of a car or the cargo hold of an airplane.Do not clean the appliance in hot or boiling water, nor to soak it in bleach or hydrogen peroxide which will cause the trays to distort or the lining to become brittle and delaminate." per tap3 patient instruction_prtd17 rev.I, the "warnings" section states the following: "patients who are sensitive to nickel or self-curing acrylic may experience allergic reactions.Per tap3 patient instruction_prtd17 rev.I, the "warnings" section states the following: the metal parts are made of medical grade stainless steel or cobalt chromium.If the patient experiences any reaction, have him/her contact the prescriber immediately.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 sleep device materials (erkoloc-pro and erkodur) 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.; 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: 12821579
• MDR Text Key: 282782340
• Report Number: 3011649314-2021-00468
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: Black Or African American