na 2900162Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 2900162 8MM RING CURETTE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074038292), received between Sep 11, 2024 and Dec 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Most reported problems
Device problems
- Break2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED WHILE ASSEMBLING THE SET. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677788 ↗MalfunctionNov 4, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR LUMBAR STENOSIS. IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING NORMAL USE IN THE DISC SPACE. ALL FRAGMENTS WERE RETRIEVED. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465430 ↗MalfunctionSep 11, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT CURETTE WAS DAMAGED DURING SET ASSEMBLY. NO PATIENT WAS INVOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190339 ↗
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
- 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
- na 907350Medtronic Sofamor Danek, Inc. · CURETTE, SURGICAL, GENERAL USE1 report
- Symmetry Surgical 23-1045Aspen Surgical Products, 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 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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