MESA® Spinal System 801-35540MRecalls & reported problems
VB Spine LLC · Deformity, Uniplanar Screw Size Ø5.5x40 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857139879), received between Dec 22, 2016 and Aug 12, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING INTRA-OPERATIVE FINAL LOCKING ON THE LEFT SIDE OF THE CONSTRUCT, A MESA DEFORMITY UNIPLANAR SCREW WOULD NOT LOCK/ENGAGE WITH A MESA STRAIGHT RAIL. SUBSEQUENTLY, THE COMPLAINT SCREW AND RAIL WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN HOUR AND A HALF SURGICAL DELAY. THIS RECORD CAPTURES THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10397691 ↗InjuryDec 22, 2016Fracture; Fracture
ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH A FRACTURED SCREW WAS REMOVED. THE PATIENT REPORTEDLY HAD A FRACTURED SCREW APPROXIMATELY 12 MONTHS POST-OP. REVISION SURGERY TOOK PLACE (B)(6) 2016.
Patient problems: Pain
MAUDE report 6200135 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- 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 VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 179788635Medos International Sàrl · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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