MESA® Small Stature Spinal System 3001-35540Recalls & reported problems
VB Spine LLC · 3001-35540 · Class 2 · Implant
All models of MESA Small Stature Spinal System (16)
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 10888857049888), received between Jun 15, 2020 and Jun 15, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2020Fracture; Fracture
IT WAS REPORTED THAT THE INNER COLLET OF 2 MESA SM STATURE SPINAL SYSTEM DEFORMITY, UNIPLANAR SCREWS; SIZE Ø5.5X40 MM BROKE DURING REDUCTION. THE SCREWS WERE LEFT IN THE PATIENT; HOWEVER, THEY WERE NOT FINAL LOCKED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A FIVE MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10155627 ↗MalfunctionJun 15, 2020Fracture; Fracture
IT WAS REPORTED THAT THE INNER COLLET OF 2 MESA SM STATURE SPINAL SYSTEM DEFORMITY, UNIPLANAR SCREWS; SIZE Ø5.5X40 MM BROKE DURING REDUCTION. THE SCREWS WERE LEFT IN THE PATIENT; HOWEVER, THEY WERE NOT FINAL LOCKED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A FIVE MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10155624 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page