DeRoyal 89-2569Recalls & reported problems
Deroyal Industries, Inc. · JIT LAMINECTOMY PACK · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756281393), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2019Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem
FUZZ ON THE OR TOWELS CAUSED LINT DURING A SURGICAL PROCEDURE. THE OR TOWELS WERE PACKAGED IN A CONVENIENCE KIT USED DURING A NEUROLOGICAL PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9125711 ↗
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- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
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- Medline Industries, Inc. DYNJ908124AMedline Industries, Inc. · General surgery tray4 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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