GEN4 INTERACTIVE 4R380E-0105018Recalls & reported problems
Curbell Medical Products, Inc. · GEN4 INTERACTIVE · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840828172868), received between Dec 11, 2024 and Jan 7, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration6
- Fracture2
Patient problems
- Failure of Implant8
- Inflammation3
- Osteolysis3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23992979 ↗InjuryDec 24, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23889386 ↗InjuryNov 18, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 23587284 ↗InjurySep 11, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 23031109 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 22753665 ↗InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 22736057 ↗InjuryMay 15, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 22029764 ↗InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 20903263 ↗
Other System, Environmental Control, Powered devices
- ARIAL CSK200-900MRSecuritas Healthcare LLC · System, environmental control, powered1 recall0 reports
- ARIAL CSK200-900Securitas Healthcare LLC · System, environmental control, powered1 recall0 reports
- ARIAL 54305Securitas Healthcare LLC · System, environmental control, powered1 recall0 reports
- Arial 0900-989Securitas Healthcare LLC · System, Environmental Control, Powered1 recall0 reports
- Arial 54600Securitas Healthcare LLC · System, Environmental Control, Powered1 recall0 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
- GEN4 INTERACTIVE 412400N-0300018Curbell Medical Products, Inc. · System, Environmental Control, Powered2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.