NSK Sterile Burs/Drills PDS-2RFUL-50Recalls & reported problems

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 04589551353446), received between Apr 13, 2026 and Apr 13, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

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

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Dural Tear1

Recent adverse event reports

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

InjuryApr 13, 2026Insufficient Device Problem Information
ON MARCH 18, 2026, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR (NSK EUROPE) AND RECEIVED INFORMATION THAT A SURGEON INJURED DURA MATER USING AN NSK SURGICAL BUR. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS. - THE EVENT OCCURRED ON MARCH 17, 2026. - THE SURGEON WAS PERFORMING A CRANIOTOMY PROCEDURE USING THE PDS-2RFUL-50 SURGICAL BUR (LOT NO. 25X1) TOGETHER WITH A P300 STANDARD ATTACHMENT (SERIAL NO. UNKNOWN). - THE SURGEON REPORTED A DUAL TEAR DURING THE PROCEDURE. - THE SURGEON ALSO REPORTED THAT THE PATIENT IS ON GOOD HEALTH CONDITION, AND THAT NO POST-OPERATIVE ISSUE IN RELATION WITH THE INCIDENT HAS BEEN REPORTED.
Patient problems: Dural Tear
MAUDE report 24854052 ↗

Device details

UDI-DI	`04589551353446`
Brand	NSK Sterile Burs/Drills
Model	PDS-2RFUL-50
Company	Nakanishi Inc.
Product code	EQJ · BUR, EAR, NOSE AND THROAT
Class	Class 1
FDA submission	K202120
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 20, 2022

Device type (GMDN): Orthopaedic bur, single-use

A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

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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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