Invictus 55405-090-080Recalls & reported problems
Alphatec Spine, Inc. · SI.Core Fenestrated Favored Angle Screw, 9.0mm X 80mm · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00190376452296), received between Apr 24, 2025 and Sep 29, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Fracture1
Patient problems
- Failure of Implant4
- Spinal deformity1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
Patient problems: Spinal deformity
MAUDE report 50936608 ↗InjuryJun 17, 2025Break; Break
A PATIENT UNDERWENT A SPINAL SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE SCREW FRACTURED AT THE NECK POSTOPERATIVELY. REVISION SURGERY IS PLANNED. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22235388 ↗InjuryApr 24, 2025Break; Break
AROUND 1 YEAR POSTOPERATIVELY, RADIOGRAPH IMAGES REVEALED THAT THE SCREW SHANK HAD FRACTURED. REVISION SURGERY WAS PERFORMED TO REMOVE THE HARDWARE. THIS IS REPORT 4 OF 4.
Patient problems: Failure of Implant
MAUDE report 21905376 ↗InjuryApr 24, 2025Break; Break
AROUND 1 YEAR POSTOPERATIVELY, IT WAS REPORTED THAT THE SCREW HAD FRACTURED AT THE NECK. REVISION SURGERY WAS PERFORMED TO REMOVE THE HARDWARE. THIS IS REPORT 3 OF 4.
Patient problems: Failure of Implant
MAUDE report 21905300 ↗InjuryApr 24, 2025Break; Break
AROUND 1 YEAR POSTOPERATIVELY, IT WAS REPORTED THAT THE SCREW HAD FRACTURED AT THE NECK. REVISION SURGERY WAS PERFORMED TO REMOVE THE HARDWARE. THIS IS REPORT 2 OF 4.
Patient problems: Failure of Implant
MAUDE report 21905288 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- 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
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.