Invictus 19000-35-24Recalls & reported problems
Alphatec Spine, Inc. · POLYAXIAL SCREW, 3.5mm X 24mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376302676), received between Aug 10, 2021 and Jun 9, 2025 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2025Break; Break
AT THE 6-MONTH POSTOPERATIVE VISIT, A RADIOGRAPH IMAGE REVEALED THE SHAFTS OF TWO SCREWS HAD BROKEN INTO THE C2 VERTEBRAE. THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22170450 ↗InjuryAug 10, 2021Fracture; Fracture
ON (B)(6) 2021, A PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL FUSION. WHILE ATTEMPTING TO PLACE A 03.5MM X 24 MM POLYAXIAL SCREW INTO THE C7 VERTEBRAL BODY, IT BROKE MID-SHANK. THE DISTAL PORTION REMAINS IN-SITU. THE SURGEON PLACED A LATERAL MASS SCREW NEXT TO THE BROKEN SCREW SHANK.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12301786 ↗
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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