DENALI® MI Spinal System M101-06540Recalls & reported problems
VB Spine LLC · Cannulated Poly Screw Size Ø6.5x40 mm · Class 2 · Implant
Data updated Oct 18, 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 10888857146952), received between Sep 29, 2015 and Sep 29, 2015 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
Patient problems
- No Code Available2
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2015Fracture
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A REVISION SURGERY TOOK PLACE IN WHICH A FRACTURED SCREW WAS REMOVED. THE PATIENT REPORTEDLY HAD A FRACTURED SCREW APPROXIMATELY 13-24 MONTHS POST-OP. REVISION SURGERY TOOK PLACE (B)(6) /2015.
Patient problems: No Code Available; No Information
MAUDE report 5110882 ↗InjurySep 29, 2015Fracture
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A REVISION SURGERY TOOK PLACE IN WHICH A FRACTURED SCREW WAS REMOVED. THE PATIENT REPORTEDLY HAD A FRACTURED ROD APPROXIMATELY 13-24 MONTHS POST-OP. REVISION SURGERY TOOK PLACE (B)(6) 2015.
Patient problems: No Code Available
MAUDE report 5110846 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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