ET III Fixture SA Regular No Mount CET3R4013SRecalls & reported problems
Hiossen, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814913021058), received between May 18, 2018 and May 18, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- Bone Fracture(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2018Fracture
IT WAS REPORTED THAT THE PLACED IMPLANT HAD BEEN FRACTURED IN THE PATIENT'S MOUTH AFTER 4 YEARS OF IMPLANTATION.
Patient problems: Bone Fracture(s)
MAUDE report 7527575 ↗InjuryMay 18, 2018Fracture
IT WAS REPORTED THAT THE PLACED IMPLANT HAD BEEN FRACTURED IN THE PATIENT'S MOUTH AFTER 45 MONTHS OF IMPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7527568 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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