na 907350Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CURETTE 907350 LARGE REVERSE ANGLE · Class 1

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074499499), received between Nov 4, 2025 and Nov 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Deformation1
Material Twisted/Bent1

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.

MalfunctionNov 4, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR TLIF PROCEDURE. IT WAS REPORTED THAT THE HANDLE OF THE INSTRUMENTS WAS BENT AND STRIPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461716 ↗

Device details

UDI-DI	`00885074499499`
Brand	na
Model	907350
Company	Medtronic Sofamor Danek, Inc.
Product code	FZS · CURETTE, SURGICAL, GENERAL USE
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	Aug 15, 2022

Device type (GMDN): Bone curette, reusable

A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Other CURETTE, SURGICAL, GENERAL USE devices

Sklar Instruments 941-1320
Sklar Corporation · CURETTE, SURGICAL, GENERAL USE
1 recall0 reports
Medtronic Reusable Instruments 2900163
Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE
11 reports
Medtronic Reusable Instruments 9560547
Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE
7 reports
Medtronic Reusable Instruments 907347
Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE
3 reports
na 2900162
Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE
3 reports
Medtronic Reusable Instruments 875-304
Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE
2 reports
Symmetry Hardy 80-1345
Aspen Surgical Products, Inc. · Curette, Surgical, General Use
1 report
Symmetry Surgical 23-1045
Aspen Surgical Products, Inc. · Curette, Surgical, General Use
1 report

All CURETTE, SURGICAL, GENERAL USE 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 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.

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