MESA® Spinal System 801-07560Recalls & reported problems
VB Spine LLC · 801-07560 · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857136984), received between Oct 13, 2022 and Oct 13, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2022Migration; Migration
A PHYSICIAN REPORTED THAT A PATIENT HAS LOST CORRECTION APPROXIMATELY SIX-YEAR POST-IMPLANTATION. THE PATIENT HAS EXPERIENCED KYPHOSIS AND, "THE HOOKS CUT OUT OF THE PATIENT'S BACK AT THE TOP," LEAVING THE PATIENT WITH TWO OPEN WOUNDS IN THE THORACIC AREA WHERE THE RODS ARE PENETRATING THE SKIN. THE PHYSICIAN REPORTS THAT THE CONSTRUCT IS STILL INTACT BUT NOT ATTACHED TO THE BONE (THE SCREWS HAVE MIGRATED); REVISION SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS IMPLANTED WITH DENALI RODS, MESA HOOKS, AND MESA PEDICLE SCREWS. THIS REPORT CAPTURES THE FIRST OF TWO MESA HOOKS.
Patient problems: Tissue Breakdown
MAUDE report 15601346 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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