Medtronic Reusable Instruments 9560546Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9560546 BONE CUR STRGHT 3.6MM · Class 1
All models of Medtronic Reusable Instruments (36)
Data updated Oct 18, 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 00673978085968), received between Jan 16, 2026 and Jan 16, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.
MalfunctionJan 16, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4/5TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L4/5 LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT WHEN USING THE CURETTE TO DISSECT AROUND THE INFERIOR ARTICULAR PROCESS OF L4, THE HANDLE BROKE. THE FRACTURE OCCURRED AT THE PART WHERE THERE IS A HOLE, AND THE PHYSICIAN SPECULATED THAT THE LOWER POSITION OF THE HOLE COMPARED TO BEFORE MAY HAVE BEEN THE CAUSE. ISSUE OCCURRED IN A NEW PRODUCT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092223 ↗
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
- na 907349Medtronic 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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