Herbst Bite Jumper 3000-0010Recalls & reported problems
Allesee Aoa-Pro · Herbst Bite Jumper · Class 1
- 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 00889989038439), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
THE DOCTOR ALLEGED THE LEFT HERBST MECHANISM AND TWO SCREWS CAME LOOSE ANT THE PATIENT SWALLOWED THE COMPONENTS. THE PATIENT VISITED THE HOSPITAL AND X-RAYS WERE TAKEN OF THE CHEST AND ABDOMEN. RESULTS OF THE X-RAYS INDICATE NO BLOCKAGE. PATIENT MONITORING FOR COMPONENTS TO PASS NATURALLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19143437 ↗
Other POSITIONER, TOOTH, PREFORMED devices
- Byte Retainer BYTERetainerTrayStraight Smile LLC · Positioner, Tooth, Preformed1,954 reports
- RETAINER KIT 100-0354Access Dental Lab, LLC · Positioner, Tooth, Preformed42 reports
- SureSmile® 1000Orametrix, Inc. · Positioner, Tooth, Preformed39 reports
- SmileSet Retainers 140-0101Ortho Dental Lab LLC · Positioner, Tooth, Preformed17 reports
- ClearCorrect System RetainerClearcorrect Operating, LLC · Positioner, Tooth, Preformed3 reports
- IPS 60-500-01-09KLS-Martin L.P. · POSITIONER, TOOTH, PREFORMED2 reports
- Essix A+ 10045Dentsply Sirona Orthodontics Inc. · POSITIONER, TOOTH, PREFORMED1 report
- Distal Jet 3000-0090Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.