Invictus 17830Recalls & reported problems
Alphatec Spine, Inc. · Final Driver, Stop · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00190376419121), received between Jan 9, 2025 and Sep 16, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Material Separation8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790714 ↗MalfunctionSep 8, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676522 ↗MalfunctionMar 30, 2026Break; 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 24737872 ↗MalfunctionFeb 26, 2026Break; 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 24455498 ↗MalfunctionFeb 24, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING FINAL TIGHTENING. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430420 ↗MalfunctionDec 19, 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 23851525 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 23830441 ↗MalfunctionMay 12, 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 22003035 ↗MalfunctionJan 9, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN TIGHTENING A SET SCREW WITH A NON-TORQUE LIMITING HANDLE. THE TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21119083 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.