Invictus 17139-045-NRecalls & reported problems
Alphatec Spine, Inc. · 4.5mm Tap, Cannulated, Navigation · Class 2
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00190376319209), received between May 6, 2021 and Dec 3, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Separation3
- Fracture1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF INTO THE LEFT L3 PEDICLE DURING A CASE. THE TIP WAS RETRIEVED. A SCREW WAS NOT ABLE TO BE PLACED IN THE PEDICLE DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23709464 ↗InjuryOct 22, 2025Break; Material Separation; Break; Material Separation
THE TAP REPORTEDLY BROKE AT THE THREADS WHEN TAPPING INTO HARD BONE. THE PIECE WAS RETRIEVED FROM THE PATIENT. PERCUTANEOUS SCREW PLACEMENT WAS NOT POSSIBLE DUE TO THE PATIENT'S BONE CONDITION AND THEREFORE, THE CASE WAS ABORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358978 ↗InjuryMay 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF INSIDE OF THE PEDICLE DURING A SPINAL PROCEDURE. THE TIP WAS UNABLE TO BE RETRIEVED FROM THE PATIENT AND REMAINS IN THE PEDICLE. THIS IS REPORT 1 OF 3.
Patient problems: Foreign Body In Patient
MAUDE report 22029286 ↗MalfunctionJul 26, 2023Fracture; Fracture
IT WAS REPORTED THE TIP OF A 4.5MM TAP, CANNULATED, NAVIGATION IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17397532 ↗InjuryMay 6, 2021Material Fragmentation; Material Fragmentation
THE DOCTOR ATTEMPTED TO BACK OUT THE TAP AND HEARD A SNAP. THE DOCTOR LOOKED DOWN AND REALIZED THE TAP HAD SNAPPED 20MM ABOVE THE THREADS. THIS CAUSED A DELAY IN SURGERY OF GREATER THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11784834 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 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.
How reports and recalls are matched · Editorial policy · Report an error on this page