na 907349Recalls & reported problems
Medtronic Sofamor Danek, Inc. · URETTE 907349 SMALL REVERSE ANGLE · Class 1
Data updated Oct 13, 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 00885074499482), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
Most reported problems
Device problems
- Break1
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.
MalfunctionJul 31, 2025Break; Break
INFORMATION WAS RECEIVED FROM A USER FACILITY REGARDING DEVICES USED FOR SPINAL FUSION. IT WAS REPORTED THAT THE BENDER, CURRETTE, REDUCER WERE BROKEN. THE TIP OF THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22673344 ↗
Other CURETTE, SURGICAL, GENERAL USE devices
- Sklar Instruments 941-1320Sklar Corporation · CURETTE, SURGICAL, GENERAL USE1 recall0 reports
- Medtronic Reusable Instruments 2900163Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE11 reports
- Medtronic Reusable Instruments 9560547Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE7 reports
- na 2900162Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE3 reports
- Medtronic Reusable Instruments 907347Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE3 reports
- Medtronic Reusable Instruments 875-304Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE2 reports
- Symmetry Hardy 80-1345Aspen Surgical Products, Inc. · Curette, Surgical, General Use1 report
- Medtronic Reusable Instruments 9560546Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE1 report
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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