MTML-CLEAR ALIGNER-DUAL ARCH

MDR report key: 5037770 · Received August 27, 2015

Report

Report Number: 3009683512-2015-00007
Event Type: Injury
Date Received: August 27, 2015
Date of Event: May 25, 2015
Report Date: July 28, 2015
Manufacturer: RAINTREE ESSIX INC.
Product Code: NXC
PMA / PMN Number: K132145
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

Additional Manufacturer Narrative · 1

THEREFORE, BECAUSE THE DEVICE MALFUNCTIONED AND THAT MALFUNCTION RESULTED IN A SERIOUS INJURY, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem · 1

IN THIS EVENT A DENTIST REPORTED THAT A PATIENT HAD BEEN WEARING THREE MTM ALIGNERS FOR ABOUT TWO MONTHS PER ALIGNER. TWO MONTHS AFTER PLACING ALIGNER #4, DURING AN APPOINTMENT WITH THE PATIENT, THE DENTIST NOTICED THAT TOOTH #26 APPEARED TO HAVE INTRUDED. THE DENTIST REMOVED THE "BUILD UP" (BUMP) FOR TOOTH #26 ON ALIGNER #4 IN AN ATTEMPT TO HAVE THE TOOTH EXTRUDE BY ITSELF. THE DENTIST HAD THE PATIENT WEAR ALIGNER # 4 FOR ABOUT 4-5 WEEKS AND AFTER WHAT WAS THOUGHT WAS SLIGHT IMPROVEMENT, GAVE THE PATIENT THE FINAL ALIGNER. THE PATIENT RETURNED TO THE DENTIST AFTER THREE WEEKS AND THE DENTIST DECIDED TO PUT THE PATIENT BACK INTO A NEW ALIGNER #4 AND REQUESTED IT BE REMADE TO ALLOW EXTRUSION. THE DENTIST WAS ADVISED EXTRUSION/INTRUSION WAS OUTSIDE THE INTENDED USE OF MTM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
568820	MTML-CLEAR ALIGNER-DUAL ARCH	ALIGNER, SEQUENTIAL	NXC	RAINTREE ESSIX INC.		6220

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention