MESA® Spinal System 801-36540MRecalls & reported problems
VB Spine LLC · Deformity, Uniplanar Screw Size Ø6.5x40 mm · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857140264), received between Mar 2, 2016 and Nov 24, 2020 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Migration2
- Break1
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- No Information3
- Discomfort2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2020Migration; Migration
IT WAS REPORTED THAT TWO MESA DEFORMITY UNIPLANAR SCREWS MIGRATED 10 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED AND THE SCREWS HAVE BEEN REPLACED. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 10891419 ↗InjuryNov 24, 2020Migration; Migration
IT WAS REPORTED THAT TWO MESA DEFORMITY UNIPLANAR SCREWS MIGRATED 10 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED AND THE SCREWS HAVE BEEN REPLACED. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 10891407 ↗MalfunctionNov 10, 2016Break; Break
ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH THE INNER COLLET OF A MESA SCREW BROKE. THE SCREW WAS LEFT IN THE PATIENT HOWEVER, THE INNER COLLET WAS RETRIEVED.
Patient problems: No Information
MAUDE report 6092050 ↗InjuryMar 2, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC ON (B)(6) 2016 THAT A ROD POPPED OUT OF A SCREW. PATIENT WAS REVISED.
Patient problems: No Information
MAUDE report 5474522 ↗InjuryMar 2, 2016Fracture; Fracture
IT WAS REPORTED TO K2M, INC ON (B)(6) 2016 THAT A POLYAXIAL SCREW FRACTURED. PATIENT WAS REVISED. DATES UNKNOWN.
Patient problems: No Information
MAUDE report 5474502 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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.
How reports and recalls are matched · Editorial policy · Report an error on this page