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DeRoyal 89-3564Recalls & reported problems

Deroyal Industries, Inc. · LUMBAR LAMINECTOMY TRAY · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756559270), received between Jan 14, 2022 and Feb 10, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Loss of or Failure to Bond1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

    SURGICAL PATTY IN THE PACK HAD A BLUE X-RAY DETECTABLE STRIP THAT DETACHED FROM THE PATTY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13505786 ↗
  • MalfunctionJan 14, 2022Detachment of Device or Device Component

    1/2" X 1/2" SURGICAL PATTIES SUPPLIED IN THE LUMBAR LAMINECTOMY PACK HAVE A BLUE X-RAY DETECTABLE STRIP WHICH DETACHED FROM THE PATTY.

    Patient problems: Insufficient Information

    MAUDE report 13257688 ↗

Other General surgery tray devices

All General surgery tray devices →

Sources and updates

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