iTero Element 5D US System 209156Recalls & reported problems
Align Technology, Inc. · Scanner · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816063020639), received between Oct 9, 2023 and Oct 9, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Convulsion/Seizure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE TREATING DOCTOR REPORTED THAT THE PATIENT WAS SCANNED ON (B)(6) 2023 AND THE PATIENT HAD A SEIZURE. DUE TO THE SEIZURE, THE PATIENT WENT TO THE EMERGENCY ROOM AND LEFT THE OFFICE IN AN AMBULANCE. IT IS UNKNOWN WHAT MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN THE CURRENT CONDITION OF THE PATIENT, HOWEVER, THE TREATING DOCTOR ASSUMES THE PATIENT IS FINE.
Patient problems: Convulsion/Seizure
MAUDE report 17897108 ↗
Other Caries Detector, Laser Light, Transmission devices
- iTero Element 5D Plus cart configuration 211484Align Technology, Inc. · Caries Detector, Laser Light, Transmission1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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