Invictus 17950-225Recalls & reported problems
Alphatec Spine, Inc. · MIS T27 Polyaxial Screwdriver, Locking · Class 1
All models of Invictus (96)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alphatec Spine Inviscus polyaxial locking screwdriver is used to place screws during minimally invasive spine surgery. The 53 reports mostly describe the tip snapping off during a procedure, sometimes leaving a fragment in the patient that had to be retrieved. Five reports mention a foreign body left in the patient, and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00190376473017), received between Feb 13, 2024 and Sep 24, 2026 — classified as 5 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Break” (54 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
- Break54
- Material Separation23
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Foreign Body In Patient5
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892126 ↗MalfunctionJun 29, 2026Break; Material Separation
THE TIP OF THE SCREWDRIVER SHEARED OFF. THE BROKEN FRAGMENT WAS RETRIEVED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659264 ↗MalfunctionJun 16, 2026Break
DURING THE PROCEDURE, THE TIP OF THE SCREWDRIVER SHEARED OFF. IT WAS SUCCESSFULLY RETRIEVED AND DISCARDED BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524093 ↗MalfunctionJun 10, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO A SCREW. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464962 ↗MalfunctionMay 27, 2026Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304452 ↗MalfunctionMay 20, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN PLACING A SCREW. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233147 ↗MalfunctionMay 6, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25105574 ↗MalfunctionMar 6, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539491 ↗MalfunctionFeb 20, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403000 ↗MalfunctionFeb 18, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377864 ↗MalfunctionFeb 3, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEARED OFF DURING FINAL TIGHTENING OF A SCREW. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250398 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE DRIVER BROKE DURING SCREW REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930223 ↗MalfunctionDec 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926442 ↗MalfunctionOct 22, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358593 ↗MalfunctionSep 3, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958851 ↗MalfunctionJul 31, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676594 ↗MalfunctionJul 29, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22650200 ↗MalfunctionJul 7, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER SNAPPED OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22420475 ↗MalfunctionMay 29, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107173 ↗MalfunctionMay 27, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092306 ↗MalfunctionMay 9, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEARED OFF DURING REMOVAL OF A SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21998779 ↗MalfunctionFeb 20, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.
Patient problems: Insufficient Information
MAUDE report 21427550 ↗MalfunctionNov 12, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO A SCREW DURING A CASE. THE SCREW WAS ATTEMPTED TO BE REMOVED, AND THE TULIP HEAD BROKE OFF OF THE SCREW SHANK WITH THE DRIVER TIP INSIDE. BOTH THE TULIP AND DRIVER TIP WERE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20668548 ↗MalfunctionNov 8, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP BROKE DURING SCREW INSERTION. THE TIP WAS REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644368 ↗MalfunctionNov 5, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING THE SCREW INTO THE ILIUM. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613048 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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.
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