N/A 945NSD2750Recalls & reported problems

Medtronic Sofamor Danek, Inc. · DILATOR SET 945NSD2750 NIM STIMULATED · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994720016), received between Jun 13, 2024 and Jun 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Use of Device Problem4

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 13, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE, DILATORS HAVE BEEN INCONSISTENT WHEN USING THE STIMULATED DILATOR (B)(6). SOME LOT NUMBERS WILL WORK AND SOME WILL NOT. THERE IS ABOUT A MICRO MILLIMETER DIFFERENCE BETWEEN THESE DILATORS THAT DO NOT ALLOW THEM TO SLIDE OVER THE (B)(6) DILATOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525899 ↗
MalfunctionJun 13, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE, DILATORS HAVE BEEN INCONSISTENT WHEN USING THE STIMULATED DILATOR SV13J033. SOME LOT NUMBERS WILL WORK AND SOME WILL NOT. THERE IS ABOUT A MICRO MILLIMETER DIFFERENCE BETWEEN THESE DILATORS THAT DO NOT ALLOW THEM TO SLIDE OVER THE SV13J033 DILATOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525891 ↗
MalfunctionJun 13, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE, DILATORS HAVE BEEN INCONSISTENT WHEN USING THE STIMULATED DILATOR (B)(6). SOME LOT NUMBERS WILL WORK AND SOME WILL NOT. THERE IS ABOUT A MICRO MILLIMETER DIFFERENCE BETWEEN THESE DILATORS THAT DO NOT ALLOW THEM TO SLIDE OVER THE (B)(6) DILATOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525887 ↗
MalfunctionJun 13, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE, DILATORS HAVE BEEN INCONSISTENT WHEN USING THE STIMULATED DILATOR SV13J033. SOME LOT NUMBERS WILL WORK AND SOME WILL NOT. THERE IS ABOUT A MICRO MILLIMETER DIFFERENCE BETWEEN THESE DILATORS THAT DO NOT ALLOW THEM TO SLIDE OVER THE SV13J033 DILATOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525879 ↗

Device details

UDI-DI	`00613994720016`
Brand	N/A
Model	945NSD2750
Company	Medtronic Sofamor Danek, Inc.
Product code	ETN · STIMULATOR, NERVE
Class	Class 2
FDA submission	K090838
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	Aug 21, 2023

Device type (GMDN): Nerve-locating system

An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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