Invictus 55405-095-100Recalls & reported problems
Alphatec Spine, Inc. · SI.Core Fenestrated Favored Angle Screw, 9.5mm X 100mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376452784), received between Jun 7, 2025 and Aug 4, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Fracture; Fracture
ABOUT ONE YEAR POSTOPERATIVELY, RADIOGRAPHIC IMAGING SHOWED TWO RIGHT SI. CORE SCREWS HAD FRACTURED AT THE NECK. NO REVISION SURGERY IS NEEDED AT THIS TIME. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22700994 ↗InjuryJun 9, 2025Break; Break
IT WAS REPORTED THAT THREE SCREWS BROKE POSTOPERATIVELY. THE TULIPS WERE REMOVED DURING REVISION SURGERY. THE SHANKS WERE UNABLE TO BE REMOVED AND REMAIN IN THE PATIENT. THIS IS REPORT 2 OF 3.
Patient problems: Failure of Implant
MAUDE report 22168471 ↗InjuryJun 7, 2025Break; Break
IT WAS REPORTED THAT THREE SCREWS BROKE POSTOPERATIVELY. THE TULIPS WERE REMOVED DURING REVISION SURGERY. THE SHANKS WERE UNABLE TO BE REMOVED AND REMAIN IN THE PATIENT. THIS IS REPORT 1 OF 3.
Patient problems: Failure of Implant
MAUDE report 22163093 ↗
Other Thoracolumbosacral pedicle screw system devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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