Invictus 55005-095-080Recalls & reported problems
Alphatec Spine, Inc. · Cannulated Iliac Favored Angle Screw, 9.5mm X 80mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 16, 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 00190376403861), received between Feb 19, 2026 and Feb 24, 2026 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Separation2
Patient problems
- Malunion of Bone1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Break; Material Separation
A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2025. IT WAS REPORTED THAT FOUR MONTHS POSTOPERATIVELY THE S2AI SCREW BROKE AT THE NECK. REVISION SURGERY OCCURRED TO REMOVE THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431806 ↗InjuryFeb 19, 2026Break; Material Separation
A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT ABOUT 12 MONTHS POSTOPERATIVELY, THE S2AI SCREW BROKE AT THE NECK. REVISION SURGERY TOOK PLACE ON (B)(6) 2026 TO REMOVE BOTH PARTS OF THE BROKEN SCREW.
Patient problems: Malunion of Bone
MAUDE report 24393922 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page