Invictus 15004-105-100Recalls & reported problems
Alphatec Spine, Inc. · Polyaxial Screw, 10.5 mm x 100 mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376136998), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Noise, Audible1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2020Break; Noise, Audible
UPON INSERTING SCREWS INTO BONE, THE SCREW DRIVER MADE A CRACKING NOISE AS THE SCREW ADVANCED INTO HARD BONE. THE WINGED TIP OF THE SCREW DRIVER SHEARED OFF AND THE DRIVER FELL APART. THIS CAUSED THE SCREW SHANK TO STRIP AND THE BUSHING TO BREAK, SUBSEQUENTLY RESULTING IN CUTTING OFF THE HEAD OF THE SCREW TO EXTRACT THE SHANK SEPARATELY. THE SECOND DRIVER BROKE WHILE INSERTING THE OTHER S2AI SCREW. THE SURGEON ATTEMPT TO HELICOPTER THE SCREW DOWN THE REST OF THE WAY WITH THE COUNTER TORQUE AND THE SCREW HEAD SHEARED OFF. THE DETACHED TULIP/SCREW HEAD WAS REMOVED BUT THE THREADED SHANK REMAINS ENTRAPPED WITHIN S2AI (SACRAL ALAR ILIAC). THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9835213 ↗
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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