MESA® Spinal System 801-37550MRecalls & reported problems
VB Spine LLC · Deformity, Uniplanar Screw Size Ø7.5x50 mm · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857140707), received between Sep 30, 2015 and Mar 1, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Slipped” (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 18, 2026.
Most reported problems
Device problems
- Device Slipped1
- Fracture1
- Malposition of Device1
- Migration1
Patient problems
- Pain2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2023Fracture; Fracture
A PATIENT WAS REVISED TO ADDRESS A FRACTURED MESA DEFORMITY SCREW AT RIGHT-SIDE L5 AND A LEFT-SIDE L5 MESA DEFORMITY SCREW WHICH WAS "LOOSE IN THE BONE." THE PATIENT REPORTED EXPERIENCING "PROGRESSIVELY MORE PAIN" APPROXIMATELY TWO-MONTHS POST-OPERATIVELY. THIS REPORT CAPTURED THE FRACTURED, RIGHT-SIDE SCREW.
Patient problems: Pain
MAUDE report 16464320 ↗InjuryMar 1, 2023Migration; Migration
A PATIENT WAS REVISED TO ADDRESS A FRACTURED EVEREST DEFORMITY SCREW AT RIGHT-SIDE L5 AND A LEFT-SIDE L5 EVEREST DEFORMITY SCREW WHICH WAS "LOOSE IN THE BONE." THE PATIENT REPORTED EXPERIENCING "PROGRESSIVELY MORE PAIN" APPROXIMATELY TWO-MONTHS POST-OPERATIVELY. THIS REPORT CAPTURED THE MIGRATED, LEFT-SIDE SCREW.
Patient problems: Pain
MAUDE report 16464318 ↗InjurySep 30, 2015Device Slipped; Malposition of Device
MANUFACTURER WAS NOTIFIED THAT A ROD IN THE DISTAL SCREW OF A LONG CONSTRUCT REPORTEDLY SLIPPED WITHIN THE SCREW HEAD CAUSING A LOSS OF CORRECTION APPROXIMATELY 3 MONTHS POST-OP.
Patient problems: No Information
MAUDE report 5113005 ↗
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.
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