Medtronic Reusable Instruments 9560547Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9560547 BONE CUR ANGLD 5.2MM · Class 1
All models of Medtronic Reusable Instruments (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00673978085975), received between Sep 13, 2024 and Apr 27, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Material Twisted/Bent1
- Nonstandard Device1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR MICROENDOSCOPIC DISCECTOMY. IT WAS REPORTED THAT IT WAS A PRODUCT THAT WAS PURCHASED LAST MONTH AND WHEN USED FOR THE FIRST TIME DURING THIS OPERATION, IT WAS BENT USING A LIGHT FORCE. THE DEVICE WAS BENT, SO IT COULD NOT BE USED; IT WAS DEALT WITH BY USING SOMETHING ELSE. WHEN THE BENT PART WAS RETURNED, IT BROKE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PRODUCT WAS NOT BENT AT THE TIME OF DELIVERY. IT WAS SAID THAT IT BROKE DURING THE VERY FIRST USE IN SURGERY. IT REPORTEDLY BROKE WITHOUT APPLYING MUCH FORCE. THIS APPEARS TO BE THE FIRST OCCURRENCE, INCLUDING LOANER INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994896 ↗MalfunctionMar 10, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN MED THERAPY. IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING RESECTION OF YELLOW LIGAMENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21557698 ↗MalfunctionFeb 12, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING MICRO ENDOSCOPIC DISCECTOMY FOR LUMBAR DISCK HERNIATION. IT WAS REPORTED THAT INSTRUMENT WAS BROKE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21362011 ↗MalfunctionJan 28, 2025Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MED FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT DURING MED INTERVERTEBRAL DECOMPRESSION, THE CURETTE BENT FROM THE BASE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21253110 ↗MalfunctionJan 25, 2025Break; Nonstandard Device; Break; Nonstandard Device
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED INSTRUMENT. PRE-OP DIAGNOSIS OF PATIENT WAS LUMBAR DISC HERNIATION. IT WAS REPORTED THAT, THE CURETTE THAT WAS USED ABOUT TWICE AFTER THE PURCHASE WAS BROKEN. THE HANDLE PORTION AND SHAFT PORTION WERE BROKEN FROM THE PERFORATED REGION, AND THE PHYSICIAN WHO USED IT PREVIOUSLY SEEMED TO HAVE EXPERIENCE. AT THAT TIME, IT WAS BELIEVED THAT THE PRODUCT HAD DETERIORATED OVER TIME, BUT THIS TIME, THE PRODUCT WAS SUSPECTED TO HAVE HAD AN INITIAL DEFECT DUE TO ITS SHALLOW USAGE. PROCEDURE OR TECHNIQUE PERFORMED WAS MICRO ENDOSCOPIC DISCECTOMY. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT, NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21236302 ↗MalfunctionJan 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MED FOR AN INDI CATION OF HERNIA. IT WAS REPORTED THAT THE CURETTE WAS BROKEN ON THE PROXIMAL SIDE DURING SURGERY. THERE WAS A DELAY IN OVERALL PROCEDURE TIME REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21236233 ↗MalfunctionSep 13, 2024Break; Product Quality Problem; Break; Product Quality Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MICRO ENDOSCOPIC DISCECTOMY (MED) SPINAL THERAPY FOR SPINAL DISC HERNIATION. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DAMAGED OCCURRED DURING INITIAL USE, SO IT IS BELIEVED THAT THE DETERIORATION WAS NOT CAUSED BY THE USE OF THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20210767 ↗
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
- 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
- Medtronic Reusable Instruments 9560546Medtronic 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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