MESA® Spinal System 801-H55495Recalls & reported problems
VB Spine LLC · 801-H55495 · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857144248), received between Aug 12, 2020 and Dec 6, 2021 — classified as 1 injury, 1 malfunction.
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 18, 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 Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2021Fracture; Fracture
IT WAS REPORTED THAT A MESA DEFORMITY STRAIGHT RAIL AND A DENALI DEFORMITY STRAIGHT ROD BROKE 18 MONTHS POST -OPERATIVELY. REVISION WILL BE PERFORMED, BUT HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE MESA DEFORMITY STRAIGHT RAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12941597 ↗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 STRAIGHT RAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10397661 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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