MAUDE Adverse Event Report: ACCESS DENTAL LAB IMPRESSION KIT

Model Number N/A

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

Patient Problem Tooth Fracture (2428)

Event Date 05/19/2022

Event Type  Injury  

Event Description

The customer reported a broken tooth while wearing the aligners, the customer was not able to provide the impacted tooth number.Medical intervention will be required.Aligner treatment was not discontinued,the customer will have dental work done to fix the tooth and then continue with the process.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).

Manufacturer Narrative

Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the impression kit caused, contributed, or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions that describe tooth (breakage) fracture.

• Brand Name: IMPRESSION KIT
• Type of Device: IMPRESSION KIT
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: bernie silvers ; 1530 antioch pike; antioch, TN 37013 ; 5127642249
• MDR Report Key: 14739093
• MDR Text Key: 294389801
• Report Number: 3014658399-2022-00130
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR