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N/A 3606290Recalls & reported problems

Medtronic Sofamor Danek, Inc. · BENDING IRON 3606290 SAGITTAL LEFT · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169529038), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Neurological Deficit/Dysfunction1
  • Neuropathy1
  • Numbness1
  • Paralysis1
  • Spinal Cord Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT INTRA-OP, THE SPINAL CORD WAS HIT BY ONE OF THE IN-SITU BENDERS. NEUROLOGICAL DEFICIT WAS REALIZED AFTER THIS EVENT OCCURRED. THE PATIENT IS REPORTED TO HAVE SYMPTOMS OF PARTIAL PARALYSIS DUE TO THIS EVENT.

    Patient problems: Neurological Deficit/Dysfunction; Neuropathy; Numbness; Paralysis; Spinal Cord Injury

    MAUDE report 9834786 ↗

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Sources and updates

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