Invictus OsseoScrew 16183-050Recalls & reported problems
Alphatec Spine, Inc. · Invictus Osseoscrew, Expansion Shaft 50mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376307329), received between Mar 25, 2021 and Jun 30, 2021 — classified as 2 injuries, 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break3
- Material Fragmentation2
Patient problems
- Insufficient Information2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2021Break; Break
THE SCREW DID NOT EXPAND PROPERLY WHEN ATTEMPTING TO REMOVE THE EXPANSION SHAFT FROM THE SCREW. THE TIP OF THE SHAFT FRACTURED. IT WAS REMOVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 12097114 ↗InjuryMar 26, 2021Break; Material Fragmentation; Material Fragmentation
STYLET BROKE DURING USE. THE DISTAL TIP WAS NOT REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11574233 ↗InjuryMar 25, 2021Break; Material Fragmentation; Material Fragmentation
TWO INVICTUS OSSEOSCREW EXPANSION SHAFTS BROKE DURING EXPANSION. ONE BROKE AT THE DISTAL THREADS, THE OTHER BROKE BEFORE THE DISTAL THREADS AND AT THE PROXIMAL END.
Patient problems: Insufficient Information
MAUDE report 11568350 ↗
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 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