RESPONDER 5, INTERACTIVE 5I41TU-901341ARecalls & reported problems
Curbell Medical Products, Inc. · RESPONDER 5, INTERACTIVE · Class 2
Data updated Oct 18, 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 00840828176217), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 injury.
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
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE. HALF OF THE SIDE WALL BROKEN AWAY FROM THE IMPLANT NECK. BOTH PARTS WERE PRESENT.
Patient problems: Failure of Implant
MAUDE report 24284357 ↗
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- Tobii Dynavox TD I-110Tobii Dynavox LLC · System, Communication, Powered1 recall0 reports
- Voalte Nurse Call 4.1Hill-Rom, Inc. · System, communication, powered14 reports
- GEN4 DIRECT ACCESS 4C370U-P10424CCurbell Medical Products, Inc. · System, Communication, Powered3 reports
- GEN4 PLUS, RESPONDER 5, ENHANCED 5C410U-10134003ACurbell Medical Products, Inc. · System, Communication, Powered3 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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