Invictus OsseoScrew 15905-065-050Recalls & reported problems
Alphatec Spine, Inc. · Invictus Osseoscrew, Polyaxial, 6.5 X 50mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376243832), received between Nov 17, 2021 and Apr 22, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2022Fracture; Fracture
AROUND ONE YEAR POSTOPERATIVELY, A PATIENT UNDERWENT REVISION SURGERY TO REMOVE A BROKEN OSSEOSCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14190532 ↗InjuryNov 17, 2021Fracture; Fracture
A 6.5 X 50MM REDUCTION SCREW WAS LOADED ON THE SCREWDRIVER AND A 50MM EXPANSION SHAFT WAS INSERTED INTO THE SCREW. THE SCREW WAS IMPLANTED UNDER FLUOROSCOPY AND THE EXPANSION SHAFT WAS VISIBLE. THERE WAS NO EXPANSION. THE SURGEON RELEASED THE TENSION AND TRIED TO REMOVE THE EXPANSION SHAFT. THE TIP OF THE SHAFT BROKE OFF INTO THE SCREW AND COULD NOT BE REMOVED. NO PATIENT INJURY REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12833097 ↗
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.
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