SURESMILE ALIGNER

Report

Report Number: 1649995-2018-00001
Event Type: Injury
Date Received: January 31, 2019
Date of Event: September 26, 2018
Report Date: January 30, 2019
Manufacturer: ORAMETRIX INC.
Product Code: NXC
PMA / PMN Number: K171860
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. PLEASE NOTE, THIS EVENT WAS ORIGINALLY SUBMITTED AS MFR REPORT # 1036212-2018-00006 UNDER DENTSPLY SIRONA ORTHODONTICS. IN THE ORIGINAL SUBMISSION, THIS EVENT WAS REPORTED UNDER THE KIT THAT IS MANUFACTURED BY DENTSPLY SIRONA ORTHODONTICS BY MISTAKE AND SHOULD HAVE BEEN REPORTED UNDER ORAMETRIX INC. SINCE THEY ARE THE MANUFACTURER OF THE DEVICE THAT CAUSED/CONTRIBUTED TO THIS EVENT. ORAMETRIX WAS RECENTLY ACQUIRED BY DENTSPLY SIRONA INC., WHO IS ALSO THE PARENT COMPANY OF DENTSPLY SIRONA ORTHODONTICS.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER USING THE SURESMILE ALIGNER. THE REPORTED SYMPTOMS INCLUDE SWOLLEN LIPS, SWOLLEN GINGIVA, NUMB TONGUE AND DIFFICULTY BREATHING. THE PATIENT WENT TO THE EMERGENCY ROOM FOR TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
87546	SURESMILE ALIGNER	ALIGNER, SEQUENTIAL	NXC	ORAMETRIX INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR		Hospitalization\| R