Invictus 17138Recalls & reported problems
Alphatec Spine, Inc. · Final Driver · Class 1
All models of Invictus (96)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00190376185811), received between Aug 10, 2020 and Sep 14, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Break” (9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break9
- Material Separation4
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break; Material Separation
It was reported that the tip of the driver sheared off during a case. The tip was retrieved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754842 ↗MalfunctionJan 15, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEARED OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081251 ↗MalfunctionJun 11, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEARED OFF WHEN FINAL TIGHTENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185707 ↗MalfunctionFeb 20, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEARED OFF DURING A CASE. THE TIP WAS RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21427814 ↗MalfunctionJul 25, 2024Break; Break
IT WAS REPORTED THAT THE DRIVER WAS FOUND BROKEN AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833774 ↗MalfunctionSep 10, 2023Break; Break
IT WAS REPORTED THE DISTAL TIP OF THE DRIVER BROKE OFF DURING THE FINAL TIGHTENING PROCESS. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17716950 ↗MalfunctionSep 29, 2022Break; Break
DURING SURGERY, THE HEXALOBE TIP SHEARED OFF. THE SURGEON USED SUCTION TO REMOVE IT FROM THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505931 ↗MalfunctionJul 16, 2021Break
THE TIPS OF BOTH FINAL DRIVERS SHEARED OFF DURING SURGERY. THEY WERE RETRIEVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185879 ↗InjuryAug 10, 2020Break; Entrapment of Device
DRIVER TIP BROKE OFF DURING FINAL TIGHTENING. THE DETACHED TIP REMAINS POSITIONED WITHIN THE IMPLANTED SET SCREW.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10385438 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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