Neodent 103.162Recalls & reported problems

JJGC Indústria e Comércio de Materiais Dentários S/A. · TWIST DRILL · Class 1

Data updated Oct 13, 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 07898237561882), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DURING A SURGICAL IMPLANT PLACEMENT PROCEDURE CARRIED OUT IN (B)(6) 2025, THE ITEM 103.162 ¿ TWIST DRILL WAS ACCIDENTALLY SWALLOWED BY THE PATIENT UNDERGOING THE PROCEDURE. WHILE A STUDENT WAS MANUALLY CHECKING THE DEPTH OF THE SURGICAL SITE DRILLING, THE DRILL FELL INTO THE PATIENT'S ORAL CAVITY AND WAS QUICKLY SWALLOWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905027 ↗

Device details

UDI-DI	`07898237561882`
Brand	Neodent
Model	103.162
Company	JJGC Indústria e Comércio de Materiais Dentários S/A.
Product code	DZA · DRILL, DENTAL, INTRAORAL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 21, 2023

Device type (GMDN): Fixture/appliance dental drill bit, reusable

A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Other DRILL, DENTAL, INTRAORAL devices

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Neodent 103.619
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All DRILL, DENTAL, INTRAORAL devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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