MESA Spinal System 6201-90050Recalls & reported problems
VB Spine LLC · MESA Rail / Rod Puller · Class 1
All models of MESA Spinal System (55)
Data updated Oct 18, 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 10888857171220), received between Feb 4, 2022 and Feb 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2022Material Deformation; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT A MESA RAIL/ROD PULLER APPEARED "PINCHED" DURING PRE-OPERATIVE DEVICE INSPECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13455991 ↗MalfunctionFeb 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIP OF A MESA DEFORMITY RAIL/ROD PULLER WAS OBSERVED TO BE 'SLIGHTLY BENT' INTRA-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13453405 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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