MAUDE Adverse Event Report: ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD BYTE IMPRESSION KIT; GENERAL PURPOSE DENTAL TRAY

Model Number	KIT
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tooth Fracture (2428)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21cfr part 803.This mdr is being submitted as a part of a retrospective review and remediation effort based on enhancements and harmonization made to the company's complaint handling processes.There is no change to device performance or to the device risk profile.A capa (2023-487) has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.This retrospective review includes the date range of 05/17/2021 through 09/17/2024.
Event or Problem Description
A patient reported "i noticed a sharp edge against my tongue in back and a tip piece of my back molar was missing.I looked in the impression and it was there, stuck in a divet in the impression so heading to get that fixed today.I'm honestly regretting this whole process." tooth #30 chipped when she did her impression.That tooth appears to have a large filling in it previously.She went to doctor of dental surgery and needs a crown.

• Brand Name: BYTE IMPRESSION KIT
• Common Device Name: GENERAL PURPOSE DENTAL TRAY
• Manufacturer (Section D): ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD; 5th floor, block d building 18; henan international university; zhengzhou, henan 45000 1; CH 450001
• MDR Report Key: 20975743
• Report Number: 3014845255-2021-00380
• Device Sequence Number: 8344512
• Product Code: OFX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2024
• Report Date (Section F): 12/19/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: KIT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/25/2021
• Event Location: Home
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/19/2024