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U.S. Department of Health and Human Services

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

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ALIGN TECHNOLOGY, INC. VIVERA RETAINER; MAINTAINER, SPACE PREFORMED, ORTHODONTIC Back to Search Results
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).
 
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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 Key15108547
MDR Text Key296656872
Report Number2953749-2022-02258
Device Sequence Number1
Product Code DYT
UDI-Device Identifier00816063020028
UDI-Public(01)00816063020028(10)0017065597(13)150630(91)0236245501R
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181739
Number of Events Reported1
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 NumberVIVEA RETAINER
Device Catalogue Number8054
Device Lot Number10103051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2022
Initial Date FDA Received07/26/2022
Supplement Dates Manufacturer Received08/05/2022
Supplement Dates FDA Received08/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age49 YR
Patient SexFemale
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