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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 3 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

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Sources and updates

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