MAUDE Adverse Event Report: ALIGNTECH DE MEXICO S, DE R. L. DE C. V. INVISALIGN; ALIGNER, SEQUENTIAL

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Laceration(s) (1946); Pain (1994); Tooth Fracture (2428)

Event Date 10/01/2022

Event Type  Injury  

Event Description

Since started wearing invisalign started to have pain in ligament and have a cracked tooth, which required root canal.Another tooth will be also evaluated for a potential crack.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGNTECH DE MEXICO S, DE R. L. DE C. V.
• MDR Report Key: 16026715
• MDR Text Key: 306067971
• Report Number: MW5113916
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White