Invictus 17109-045Recalls & reported problems
Alphatec Spine, Inc. · 4.5mm Tap, Cannulated · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190376192055), received between Apr 13, 2021 and Feb 12, 2026 — classified as 6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Fragmentation2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT THE TAP HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24329036 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THE TAP IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 22340995 ↗MalfunctionSep 11, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191864 ↗MalfunctionOct 16, 2023Fracture; Fracture
WHILE PREPARING THE SCREW HOLE, THE DISTAL TIP OF THE TAP BROKE OFF IN THE PEDICLE. THE SURGEON RETRIEVED THE BROKEN PIECE. IT WAS REPORTED THE PATIENT HAD INCREDIBLY DENSE, SCLEROTIC BONE. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17946115 ↗MalfunctionJun 19, 2022Material Fragmentation; Material Fragmentation
THE DISTAL END OF BOTH TAPS BROKE OFF INSIDE THE PATIENT'S BONE. THE PATIENT HAD A VERY SCLEROTIC BONE. THE SURGEON WAS ABLE TO RETRIEVE BOTH BROKEN PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14741293 ↗MalfunctionApr 13, 2021Material Fragmentation; Material Fragmentation
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.