MESA Spinal System 801-90038Recalls & reported problems
VB Spine LLC · Dual Action Rod Reducer Dragonfly™ · Class 1
All models of MESA Spinal System (55)
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 10888857143098), received between Jul 15, 2020 and Jul 15, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Jam” (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
- Mechanical Jam1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT A MESA DUAL ACTION ROD REDUCER DRAGONFLY TIP BECAME DEFORMED AND WAS NOT ABLE TO BE REMOVED AFTER INTRA-OPERATIVE LOCKING. THE SURGEON REMOVED A PORTION OF THE PATIENT'S BONE SURROUNDING THE INSTRUMENT IN AN ATTEMPT TO REMOVE IT. THE SURGEON WAS FINALLY ABLE TO REMOVE THE INSTRUMENT WITH A MALLET AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10-20 MINUTE SURGICAL DELAY.
Patient problems: Injury
MAUDE report 10280019 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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