MESA® Spinal System 801-07540DRecalls & reported problems
VB Spine LLC · 801-07540D · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857136793), received between Oct 12, 2016 and Sep 15, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam
IT WAS REPORTED THAT 4 MESA FOUNDATION SCREWS BROKE AND THE INNER COLLETS GOT "STUCK INTO THE ROD" INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD WILL CAPTURE THE FOURTH OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478053 ↗InjuryOct 12, 2016Break; Break
ON 09/12/2016 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH A BROKEN SCREW WAS REMOVED. THE PATIENT REPORTEDLY HAD A BROKEN SCREW LESS THAN ONE MONTH POST-OP. REVISION SURGERY TOOK PLACE (B)(6) 2014.
Patient problems: Pain
MAUDE report 6024166 ↗
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- 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
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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