Invictus 17109-055Recalls & reported problems
Alphatec Spine, Inc. · 5.5mm Tap, Cannulated · Class 1
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00190376192079), received between May 9, 2022 and Aug 26, 2026 — classified as 5 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Break” (17 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
- Break17
- Material Separation6
- Fracture4
- Damaged Thread1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Foreign Body In Patient5
- Insufficient Information2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456923 ↗MalfunctionMar 10, 2026Break; Material Separation
IT WAS REPORTED THAT THE TAP HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561094 ↗MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT THE TAP WAS DAMAGED AFTER GOING THROUGH THE WASH IN STERILE PROCESSING AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326549 ↗MalfunctionDec 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TAP HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930907 ↗MalfunctionJul 18, 2025Break; Material Separation; Break; Material Separation
DURING THE PROCEDURE, A CANNULATED TAP WAS INSERTED OVER THE GUIDE WIRE. WHILE ATTEMPTING TO MAINTAIN THE INTENDED TRAJECTORY, THE TAP FRACTURED, RESULTING IN THE THREADED PORTION BREAKING OFF AND REMAINING WITHIN THE PEDICLE. THE THREADED FRAGMENT WAS SUBSEQUENTLY REMOVED FROM THE PEDICLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22542612 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THE TAP IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 22341220 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THE TAP IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 22341149 ↗InjuryNov 21, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF INTO THE PATIENT'S BONE AND REMAINS THERE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 20750470 ↗InjuryOct 15, 2024Break; Material Separation; Break; Material Separation
DURING A SPINAL PROCEDURE, IT WAS REPORTED THAT THE THREADED PORTION OF THE CANNULATED TAP BROKE OFF INSIDE THE PATIENT'S VERTEBRAL BODY. IT WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 20452536 ↗MalfunctionOct 8, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE TAP IS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20402499 ↗MalfunctionJul 17, 2024Break; Break
IT WAS REPORTED THAT THE DISTAL TIP OF THE TAP SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19766155 ↗InjuryJul 11, 2024Break; Break
IT WAS REPORTED THAT WHILE TAPPING A HOLE IN THE PATIENT'S BONE, THE TAP SHEARED OFF. THE SHEARED TIP REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19724520 ↗MalfunctionJun 27, 2024Break; Break
IT WAS REPORTED THAT THE TAP WAS RECEIVED WITH THE TIP BROKEN OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19627532 ↗InjuryJun 21, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF INTO THE PATIENT'S BONE. THE TIP REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19589834 ↗MalfunctionJun 14, 2024Damaged Thread; Damaged Thread
IT WAS REPORTED THAT THE DISTAL END OF THE TAP SPLAYED DURING A CASE. THERE WAS NO REPORT OF PATIENT INJURY DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19539133 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT A TAP BROKE DURING A SPINAL SURGERY PROCEDURE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080147 ↗MalfunctionMar 27, 2024Break; Break
IT WAS REPORTED THAT THE TAP BROKE DURING A CASE. ALL PIECES WERE RETRIEVED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986937 ↗InjuryOct 16, 2023Fracture; Fracture
WHILE PREPARING THE SCREW HOLE, THE DISTAL TIP OF THE TAP BROKE OFF IN THE PEDICLE AND COULD NOT BE RETRIEVED. IT WAS REPORTED THE PATIENT HAD INCREDIBLY DENSE, SCLEROTIC BONE. THIS IS REPORT 1 OF 2.
Patient problems: Foreign Body In Patient
MAUDE report 17945658 ↗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 16882317 ↗MalfunctionOct 26, 2022Fracture; Fracture
IT WAS REPORTED THE TIP OF A 5.5MM TAP BROKE INTO 3 PIECES DURING SURGERY. ALL OF THE PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677586 ↗MalfunctionSep 24, 2022Break; Break
THE DISTAL TIP IS BROKEN OFF. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15477294 ↗MalfunctionMay 9, 2022Break; Break
THE TIP OF A TAP SHEARED OFF IN THE PATIENT'S PEDICLE. IT WAS RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14342256 ↗
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
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · 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 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.
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