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

Model Number VIVERA RETAINERS

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "general risks to patients - existing dental restorations (e.G.- crowns) may become dislodged and require re-cementation or, in some instances, replacement" and "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 "health of the bone and gums which support the teeth may be impaired or aggravated".A potential root cause was not provided; however, the treating doctor shared that "with the vivera retainers", the patient suffered the reported symptoms.No conclusive evidence has been provided that supports or opposes the fact that the vivera retainers caused the reported symptoms.Based on the available information, the patient reported requiring intervention (re-implantation of tooth #9) to prevent a permanent impairment to body structure and the vivera product was being used, and therefore, this event is being filed as an mdr.

Event Description

The patient reported the symptoms of tooth avulsion (tooth #9), which resulted in the tooth extraction and re-implantation of tooth #9, and a new buccal wire was added to fix it.The patient also reported having a root canal treatment to keep the tooth in place (tooth #9).The patient reported requiring the following medical intervention: extraction and re-implantation of tooth #9, new buccal wire, and root canal to alleviate the reported symptoms of tooth avulsion.It is unknown if the patient was prescribed any medication to alleviate the reported symptoms.It is unknown if the patient is continuing the use of the vivera retainers.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "general risks to patients - existing dental restorations (e.G.- crowns) may become dislodged and require re-cementation or, in some instances, replacement" and "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 "health of the bone and gums which support the teeth may be impaired or aggravated".The potential root cause of this event could have been the removal of the upper vivera retainer, and vivera retainer wear.Based on the available information, the patient reported requiring intervention (re-implantation of tooth #9) to prevent a permanent impairment to body structure and the vivera product was being used, and therefore, this event is being filed as an mdr.Corrected/added data: b3: corrected the date of the event to september 26, 2023.B5: corrected that the patient is discontinuing the use of the vivera retainers (date of discontinuation unknown).Clarified event description.B7: added additional pre-existing condition to include that tooth #9 was retained with a bonded retainer attached to the 2 two adjacent teeth.H10: updated potential root cause.

Event Description

The patient reported the symptoms of tooth avulsion (tooth #9), which resulted in the tooth extraction and re-implantation of tooth #9, and a new buccal and labial wire was added to fix it.The patient also reported having a root canal treatment to keep preserve the tooth in the mouth (tooth #9).The patient reported requiring the following medical intervention: extraction and re-implantation of tooth #9, new buccal and labial wire, and root canal to alleviate the reported symptoms of tooth avulsion.It is unknown if the patient was prescribed any medication to alleviate the reported symptoms.The patient reported discontinuing the use of the vivera retainers (date unknown).

• Brand Name: VIVERA RETAINERS
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 18016430
• MDR Text Key: 326675063
• Report Number: 2953749-2023-03141
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020028
• UDI-Public: (01)00816063020028(10)0159255409(13)230818(91)21461047XXR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIVERA RETAINERS
• Device Catalogue Number: 7883
• Device Lot Number: 159255409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female