GEN4 INTERACTIVE 412400N-0300018Recalls & reported problems
Curbell Medical Products, Inc. · GEN4 INTERACTIVE GEN4 INTERACTIVE · Class 2
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 00840828173353), received between Jun 13, 2025 and Jun 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Loss of Osseointegration1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 22341137 ↗InjuryJun 13, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22203863 ↗
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- Arial 54600Securitas Healthcare LLC · System, Environmental Control, Powered1 recall0 reports
- Arial 0900-989Securitas Healthcare LLC · System, Environmental Control, Powered1 recall0 reports
- GEN4 INTERACTIVE 4R380E-0105018Curbell Medical Products, Inc. · System, Environmental Control, Powered8 reports
- GEN4 INTERACTIVE 4Z19EE-Z100038Curbell Medical Products, Inc. · System, Environmental Control, Powered3 reports
- GEN4 INTERACTIVE 4M380E-Z103018Curbell Medical Products, Inc. · System, Environmental Control, Powered2 reports
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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