Invictus 17139-055-NRecalls & reported problems
Alphatec Spine, Inc. · 5.5mm 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 00190376319223), received between Mar 31, 2022 and May 15, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component1
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 2 OF 3.
Patient problems: Foreign Body In Patient
MAUDE report 22029327 ↗InjuryJun 28, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF INTO THE PATIENT'S BONE WHEN REVERSING DIRECTION TO REMOVE IT FROM THE PEDICLE. THE TIP OF THE TAP REMAINS IN THE PATIENT. THERE WAS A GREATER THAN 30 MINUTE DELAY IN SURGERY DUE TO THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 19634495 ↗MalfunctionJan 10, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE TIP OF A TAP BROKE OFF INSIDE THE PEDICLE DURING A SPINAL PROCEDURE. THE SURGEON WAS ABLE TO RETRIEVE THE TIP FROM THE BONE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489736 ↗MalfunctionMay 5, 2023Fracture; Fracture
IT WAS REPORTED THE TIP OF A TAP BENT DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16882318 ↗InjuryMar 31, 2022Break; Break
THE SURGEON USED THE TAP, AND IT BROKE OFF IN THE VERTEBRAL BODY. IT WAS REPORTED THE PATIENT HAD VERY HARD BONE. THE SURGEON WAS ABLE TO RETRIEVE THE TAP TIP FROM THE PATIENT; HOWEVER, IT DID CAUSE A DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13958208 ↗
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