Invictus 17950-NRecalls & reported problems
Alphatec Spine, Inc. · MIS T27 Polyaxial Screwdriver, Locking, Navigation · Class 2
Quick summary
This Alphatec Spine Invictus 17950-N screwdriver is a hand tool used to tighten and adjust screws during minimally invasive spine surgery, including navigated procedures. Most of the 36 reports describe the tool breaking during a case, often with the tip shearing off, and in some instances pieces separating or remaining in the patient. There are 2 injuries and no deaths. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00190376475202), received between Nov 20, 2024 and Sep 24, 2026 — classified as 2 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Break” (34 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
- Break34
- Material Separation24
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Foreign Body In Patient3
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 34 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 50886589 ↗MalfunctionSep 24, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886419 ↗MalfunctionMay 6, 2026Break
THE TIP OF THE SCREWDRIVER WAS BROKEN OFF WHILE ATTEMPTING TO ADJUST A SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094360 ↗MalfunctionApr 29, 2026Break
THE TIP OF THE SCREWDRIVER BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028608 ↗MalfunctionApr 9, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A DAMAGED TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831138 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 24642401 ↗MalfunctionMar 11, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP WAS DISCOVERED SHEARED OFF AFTER A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572657 ↗MalfunctionMar 5, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER ARRIVED WITH A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524917 ↗MalfunctionFeb 2, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24238971 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT THE DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210395 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT THE DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210223 ↗MalfunctionJan 26, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF HTE DRIVER BROKE OFF WHEN INSERTING A SCREW. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178497 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930985 ↗MalfunctionDec 30, 2025Break; Break
IT WS REPORTED THAT THE DRIVER BROKE DURING SCREW REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929952 ↗MalfunctionDec 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 23707577 ↗MalfunctionNov 21, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING SCREW INSERTION. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621306 ↗MalfunctionNov 18, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585706 ↗MalfunctionNov 4, 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 23465799 ↗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 23358474 ↗InjuryOct 16, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN PLACING A SCREW INTO A PATIENT. THE TIP OF THE DRIVER REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23311560 ↗MalfunctionOct 16, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN PLACING A SCREW INTO A PATIENT. THE TIP WAS RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 23311513 ↗MalfunctionSep 17, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076322 ↗MalfunctionAug 25, 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 22884677 ↗MalfunctionAug 20, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS NOT LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22851324 ↗MalfunctionJul 7, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THIS IS REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22421287 ↗
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- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.