DLC Drill Stop DSN13Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · 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 10841307125396), received between Sep 5, 2022 and Sep 5, 2022 — 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. How this data works · Data updated Oct 13, 2026.

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.

InjurySep 5, 2022Fracture; Fracture
PER COMPLAINT 84271, AFTER CLINICAL PROCEDURE, THERE WAS A BROKEN OR FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 15355336 ↗

Device details

UDI-DI	`10841307125396`
Brand	DLC Drill Stop
Model	DSN13
Company	Implant Direct Sybron Manufacturing LLC
Product code	NDP · Accessories, Implant, Dental, Endosseous
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	Mar 9, 2021

Device type (GMDN): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Other Accessories, Implant, Dental, Endosseous devices

N/A 68015189
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
388 reports
N/A 68015191
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
319 reports
N/A 68015193
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
283 reports
N/A 68015187
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
266 reports
N/A 68015188
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
185 reports
N/A 68015192
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
159 reports
N/A 68015190
Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous
147 reports
NobelReplace® 37045
Nobel Biocare AB · Accessories, implant, dental, endosseous
2 recalls0 reports

All Accessories, Implant, Dental, Endosseous 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.

How reports and recalls are matched · Editorial policy · Report an error on this page