Invictus 17412Recalls & reported problems
Alphatec Spine, Inc. · Reduction Tulip Inserter · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376270241), received between Jun 3, 2022 and Jun 3, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
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.
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2022Physical Resistance/Sticking
DURING AN MIS TLIF L4-L5 SURGERY, THE SURGEON ATTEMPTED TO "POP" ON THE LOADED EXTENDED TAB TULIP AT L5, BUT IT WOULD NOT GO ON. ANOTHER ATTEMPT WAS MADE AT L4 WITHOUT SUCCESS. THE TULIP WAS SWITCHED OUT AND THE NEW ONE DEPLOYED NORMALLY AT L4. A SECOND ATTEMPT WAS MADE AT L5, BUT THE TULIP WOULD NOT GO ON. THE SURGEON WAS ABLE TO SWITCH OUT THE SHANK FOR AN ASSEMBLED SCREW AT L5 WITH NO FURTHER ISSUES. IT WAS REPORTED THIS ADDED 30-40 MINUTES TO THE SURGERY. UPON CLEANUP THE FOLLOWING DAY, THE INSERTERS USED DURING SURGERY WERE INSPECTED AND SEEMED "JAMMED". ONE OF THE EXTENDED TAB TULIPS LOOKED LIKE THE RING HAD BEEN DEPLOYED AND WOULDN'T ATTACH TO THE SHANK. THE OTHER TULIP HEADS "POPPED" ON THE SHANK BUT COULDN'T BE DEPLOYED AS BOTH INSERTERS WERE NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599061 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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