MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE, PRODUCT CODE: LRK; EMA

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This incident is currently under investigation; once completed, a supplemental report will be submitted.As of the time of this report, the reported device had not yet been received, and we are unclear if it will be provided.Further follow-up is being conducted.

Event Description

It was reported that a night guard broke during the middle of the night.The patient was awakened by a loud pop and a sharp point in the left side of her cheek.It was determined that the top piece of the snore guard had snapped into 2 pieces right behind her eye tooth (canine tooth).Patient was thankful that she did not swallow the broken piece.Additional information received, the patient did not suffer any adverse event nor serious injury, just felt like she may of had a small cut on the inside of the left cheek that resolved right away.The appliance was checked back (b)(6) 2017 when she went to the doctor's office for her cleaning.She stated that the doctor said it was in good condition.The incident occurred the night of the (b)(6) october.Further clarification was received that the mandibular section broke in ½, no photos and unsure if the device is available for return.

• Brand Name: ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE, PRODUCT CODE: LRK
• Type of Device: EMA
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer Contact: andrea hunter ; 2212 dupont dr.; suite p; irvine, CA 92612 ; 9494402635
• MDR Report Key: 7053960
• MDR Text Key: 93080494
• Report Number: 3011649314-2017-00087
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Weight: 70