Invictus 15025-075-045Recalls & reported problems
Alphatec Spine, Inc. · Cannulated Extended Tab Polyaxial Reduction Screw, 7.5 mm x 45 mm · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376117027), received between Sep 22, 2021 and Oct 11, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Separation Failure1
Patient problems
- Failure of Implant3
- Foreign Body In Patient1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Separation Failure; Separation Failure
A MALE PATIENT UNDERWENT A SPINAL PROCEDURE WHERE POSTERIOR FIXATION WAS IMPLANTED FROM L3 TO S1. DURING A POSTOPERATIVE FOLLOW-UP, A RADIOGRAPH IMAGE REVEALED THE BILATERAL SCREWS AT S1 STILL HAD THE DISTAL PORTION OF THE EXTENDED TABS ATTACHED TO THE SCREW TULIP. IT WAS REPORTED THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 20432162 ↗MalfunctionJun 6, 2024Break; Break
POSTOPERATIVELY OF A SPINAL SURGERY, A PATIENT REPORTED LIFTING SOMETHING HEAVY AND HEARING A POP. RADIOGRAPH IMAGE REVEALED A BROKEN SCREW. THERE ARE NO PLANS OF REVISION SURGERY.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 19480543 ↗InjurySep 22, 2021Fracture; Fracture
A PATIENT UNDERWENT A LUMBAR SPINAL FUSION SURGERY ON (B)(6) 2020. POSTOPERATIVELY, IT WAS DISCOVERED A SCREW HAD FRACTURED. ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 12517081 ↗
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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
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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