Invictus 17140Recalls & reported problems
Alphatec Spine, Inc. · MIS Polyaxial Screwdriver, Navigation · Class 2
Quick summary
This Alphatec Spine Invictus MIS Polyaxial Screwdriver is a hand tool used to tighten screws during spine surgery. The 47 reports mostly describe the tip snapping off during a case, and in a few instances a piece was left in the patient. Four injuries and no deaths were reported, and 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
- 44
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00190376195902), received between Nov 30, 2021 and Apr 29, 2026 — classified as 4 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (42 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
- Break42
- Material Separation19
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information4
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Break
THE TIP OF THE SCREWDRIVER BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031896 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT THE DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744118 ↗MalfunctionMar 13, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594322 ↗MalfunctionMar 12, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER TIP HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580271 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523995 ↗MalfunctionFeb 24, 2026Break
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 24433415 ↗MalfunctionFeb 19, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO A SCREW HEAD DURING INSERTION. THE SCREW WITH DRIVER TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389205 ↗MalfunctionDec 31, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23937499 ↗MalfunctionDec 31, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING A PELVIC SCREW INTO THE PELVIS. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935324 ↗MalfunctionDec 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF REMOVING A SCREW THAT HAD GOOD BONE PURCHASE. THE SCREW WAS BEING REMOVED TO PLACE A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810864 ↗MalfunctionDec 15, 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 23804598 ↗MalfunctionNov 12, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING A 8.5MM SCREW INTO SCLEROTIC BONE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535075 ↗MalfunctionNov 11, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528604 ↗MalfunctionOct 16, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING A SCREW INTO A PATIENT. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311312 ↗MalfunctionSep 4, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO A TULIP HEAD DURING A CASE. THE SCREW WITH DRIVER TIP WERE BOTH SUCCESSFULLY REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963936 ↗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 22851277 ↗MalfunctionAug 6, 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 22731848 ↗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 22646744 ↗InjuryJul 16, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE INSERTING A SCREW. THE TIP REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22525692 ↗MalfunctionMay 20, 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 22056600 ↗MalfunctionMay 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING INSERTION OF A SCREW. THE TIP WAS RETRIEVED FROM THE PATIENT. THIS IS REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029365 ↗MalfunctionMay 9, 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 21998772 ↗MalfunctionNov 20, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING A SCREW. THE TIP WAS REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20740916 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20087427 ↗InjuryAug 28, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN THE SCREW DURING INSERTION. THE TIP COULD NOT BE RETRIEVED. THE BROKEN TIP WILL REMAIN IN PLACE AS A ROD AND SET SCREW WERE PLACED OVER IT COMPLETING THE CONSTRUCT. THIS IS REPORT 2 OF 2.
Patient problems: Foreign Body In Patient
MAUDE report 20087009 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.