Invictus 19000-55-30Recalls & reported problems
Alphatec Spine, Inc. · POLYAXIAL SCREW, 5.5mm X 30mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376303697), received between Feb 20, 2023 and Oct 25, 2024 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Break; Material Separation; Break; Material Separation
A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE AT C2-T3. IT WAS REPORTED THAT WHILE INSERTING THE POLYAXIAL SCREW AT T1, IT BROKE AT THE TRANSITION PORTION OF THE SHANK BETWEEN THE TREADS AND TULIP HEAD. THE BROKEN SCREW SHANK WAS REMOVED FROM THE PATIENT. THIS CAUSED GREATER THAN 30 MINUTES OF A DELAY IN SURGERY. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539053 ↗MalfunctionOct 25, 2024Break; Material Separation; Break; Material Separation
A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE AT C2-T3. IT WAS REPORTED THAT WHILE INSERTING THE POLYAXIAL SCREW AT C2, IT BROKE AT THE TRANSITION PORTION OF THE SHANK BETWEEN THE TREADS AND TULIP HEAD. THE BROKEN SCREW SHANK WAS REMOVED FROM THE PATIENT. THIS CAUSED GREATER THAN 30 MINUTES OF A DELAY IN SURGERY. THIS IS REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535977 ↗MalfunctionFeb 20, 2023Break; Break
ON (B)(6) 2023, A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE. DURING SCREW INSERTION, THE RATCHETING HANDLES WERE TORQUING OUT AND WOULD NOT FULLY DRIVE THE SCREW IN. THE POLYAXIAL SCREW BROKE JUST BELOW THE TULIP. ALL THE PIECES WERE RETRIEVED, AND A NEW SCREW WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16402168 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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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