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DeRoyal D6205Recalls & reported problems

Deroyal Industries, Inc. · St. Carbon Steel Blades · Class 1

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 00749756144544), received between Dec 10, 2020 and Dec 10, 2020 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1
  • Material Integrity Problem1

Patient problems

  • Nervous System Injury1

Recent adverse event reports

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

  • InjuryDec 10, 2020Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

    THE KNIFE BLADE BROKE AS THE DISC SPACE WAS BEING INCISED BY PHYSICIAN AND ASSISTANT WAS HOLDING THE NERVE ROOT RETRACTOR TO PROTECT THE SPINAL CORD. AS IT BROKE, THE BROKEN FRAGMENT TORE THE DURA. THE NERVE ROOT AND CSF WERE VISIBLE. THIS WAS REPAIRED WITH DURAGEN AND FIBRIN GLUE.

    Patient problems: Nervous System Injury

    MAUDE report 10985073 ↗

Other BLADE, SCALPEL devices

All BLADE, SCALPEL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.