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

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned.An investigation will be completed once the sample has been returned and a supplemental report will be submitted.Age: asked, but unknown.Date of birth: asked, but unknown.Weight: asked, but unknown.Ethnicity: asked, but unknown.Race: asked, but unknown.Date of event: asked, but unknown.Model number: not applicable.Catalog number: not applicable.Lot number: not applicable.Expiration date: not applicable.Udi number: not available.Reporter's address: unknown.Occupation: patient/end user.Device manufacturer date: unknown.

Event Description

It was reported that the acrylic around the anchor in an extra silent nite is delaminating and falling apart in the patients mouth.No other details were provided.It is unknown whether or not the patient has any known allergies.

Manufacturer Narrative

Corrected data: section h: h1 corrected from serious injury to malfunction.This complaint will be kept on record for track and trending purposes.

Manufacturer Narrative

The investigation has been completed and the results are as follows: device history record: no dhr was available for review since the device was fabricated per physician's prescription only.Returned sample inspected: the device was not returned for investigation.Root cause: the root cause cannot be explicitly determined since the device was not returned for investigation.It was unknown that the anchor broke off was resulted from incomplete curing.This complaint will be kept on record for track and trending purposes.

• Brand Name: XTRA SILENT NITE
• Type of Device: ANTI SNORING NIGHTGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9078316
• MDR Text Key: 162384352
• Report Number: 3011649314-2019-00538
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K972424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention