MESA® Spinal System 6201-05535Recalls & reported problems
VB Spine LLC · 6201-05535 · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857163751), received between Jan 29, 2016 and Sep 27, 2019 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Migration2
- Break1
- Device Issue1
Patient problems
- Injury2
- No Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2019Device Dislodged or Dislocated; Migration; Migration
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REMOVE TWO MESA POLYAXIAL DEFORMITY SCREWS WHICH HAD "BACKED-OUT" TWO WEEKS AFTER IMPLANTATION.
Patient problems: Injury
MAUDE report 9131873 ↗InjurySep 27, 2019Device Dislodged or Dislocated; Migration; Migration
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REMOVE TWO MESA POLYAXIAL DEFORMITY SCREWS WHICH HAD "BACKED-OUT" TWO WEEKS AFTER IMPLANTATION.
Patient problems: Injury
MAUDE report 9131872 ↗MalfunctionJun 3, 2016Device Issue; Device Issue
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT TWO POLYAXIAL SCREWS WERE ONLY ABLE TO BE PARTIALY LOCKED INTRA-OP.
Patient problems: No Information
MAUDE report 5698003 ↗InjuryJan 29, 2016Break; Break
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2015 IN WHICH A FRACTURED SCREW WAS REMOVED.
Patient problems: No Information
MAUDE report 5398390 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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