MAUDE Adverse Event Report: RAINTREE ESSIX INC. MTML-CLEAR ALIGNER-DUAL ARCH; ALIGNER, SEQUENTIAL

Catalog Number MTML-AL-DA

Device Problems Structural Problem (2506); Malposition of Device (2616)

Patient Problems Therapeutic Effects, Unexpected (2099); No Information (3190)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

The dentist wanted new aligners to correct the unintended movement.The dentist was advised extrusion/intrusion was outside the intended use of mtm.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.

Event Description

In this event it was reported a patient had been wearing mtm aligners and during the their most recent visit to the dentist, it appeared as though the incisal edge across #8 and #9 had become uneven since their previous visit, specifically the #9 seemed to have become intruded.

Manufacturer Narrative

The cause of noted intrusion of the upper cannot be determined.The doctor gave aligners to patient - stating that she labels the bags with dates the patient should start using them.Returned upper appliance had been altered by the doctor to continue moving teeth and to address the noted intrusion of the left central.Returned appliances meet spec.

• Brand Name: MTML-CLEAR ALIGNER-DUAL ARCH
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): RAINTREE ESSIX INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer (Section G): ORTHOLAB; 2525 3 mile rd.; racine WI 53404
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5169542
• MDR Text Key: 29011264
• Report Number: 1036212-2015-00002
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MTML-AL-DA
• Device Lot Number: 8608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 75 YR