MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. MTML-CLEAR ALIGNER-DUAL ARCH; ALIGNER, SEQUENTIAL

Catalog Number MTML-AL-DA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The patient will require another type of orthodontic appliance to correct the open bite because the mtm aligner process does not allow for this type of correction.Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event 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.

Event Description

It was reported that a patient being treated with mtm aligner therapy was experiencing headaches, jaw pain as well as an open bite.Further discussions with the patient determined that she was wearing spacers with the aligners, which is not part of the treatment and no where is it indicated on the treatment plan.

• Brand Name: MTML-CLEAR ALIGNER-DUAL ARCH
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota, fl
• Manufacturer (Section G): ORTHOLAB; 2525 3 mile rd.; racine, wi
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 9827672
• MDR Text Key: 191585637
• Report Number: 1036212-2020-00001
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MTML-AL-DA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention