MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; MAINTAINER, SPACE PREFORMED

Model Number VIVERA RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms.This event is being filed as an mdr as the patient reported an losing an entire dental implant while an invisalign product was being used.This psa has exceeded the 30 day calendar completion guideline, as this complaint was received on october 23, 2018, and was not reported to the appropriate department until november 26, 2018.

Event Description

The patient reported a loss of a dental restoration (implant).The patient did not report requiring any medical intervention to alleviate the reported symptom.The patient did not report requiring any medication to alleviate the reported symptom.The treatment has not been discontinued as the patient is still wearing the retainers.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: MAINTAINER, SPACE PREFORMED
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 8153403
• MDR Text Key: 130115738
• Report Number: 2953749-2018-02230
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIVERA RETAINER
• Device Catalogue Number: 8579
• Device Lot Number: 23406987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR