MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. VIVERA RETAINER; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Model Number VIVEA RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "general risks to patients - existing dental restorations (e.G: crowns, bridges) may become dislodged and require re-cementation or, in some instances, replacement," "a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the useful life of the tooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work, and/or the tooth may be lost," and "the health of the bone and gums which support the teeth may be impaired and aggravated." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused the reported symptom.This event is being filed as an mdr as the patient reported tooth loss (serious injury) and the invisalign product was being used.This psa has exceeded the 30 calendar day reporting requirement since the psa was moved to regulatory assessment on (b)(6) 2022.

Event Description

The patient reported loss of unspecified tooth.It is unknown if the patient required any medical intervention to alleviate the reported symptom.It is unknown if the patient was prescribed any medication to alleviate the reported symptom.It is unknown if the patient is continuing the use of the retainers.

Event Description

This is the first follow up report to 2953749-2022-02258.

Manufacturer Narrative

Upon review, it was found that the udi field had minor errors.Following is the correction for the udi.D4: udi - (b)(4).

• Brand Name: VIVERA RETAINER
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: aaheli poddar ; 2820 orchard parkway; san jose, CA 95134 ; 4084701340
• MDR Report Key: 15108547
• MDR Text Key: 296656872
• Report Number: 2953749-2022-02258
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020028
• UDI-Public: (01)00816063020028(10)0017065597(13)150630(91)0236245501R
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• 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: 08/11/2022

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: VIVEA RETAINER
• Device Catalogue Number: 8054
• Device Lot Number: 10103051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Sex: Female