Invictus 15004-095-090Recalls & reported problems
Alphatec Spine, Inc. · Polyaxial Screw 9.5 mm x 90 mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 16, 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 00190376136554), received between Mar 4, 2021 and Feb 8, 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 16, 2026.
Most reported problems
Device problems
- Fracture2
- Break1
- Migration1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2022Fracture; Migration; Fracture; Migration
ON (B)(6) 2021, A (B)(6) Y/O MALE UNDERWENT A SPINAL FUSION AT L2-L3 & L4-L5 LTP WITH T10-P PSF. AROUND 2 MONTHS POSTOPERATIVELY, THE PATIENT REPORTS TO HEARING A LOUD CRACK WHILE GETTING UP FROM A CHAIR. THE PATIENT REPORTS TO HAVING AN INCREASE IN SYMPTOMS. A RADIOGRAPH REVEALS SCREW LOOSENING WITH BROKEN ILIAC SCREW. A REVISION SURGERY WAS PERFORMED WITH L5-S1 TLIF, REPLACEMENT OF L4 SCREWS AND CONNECTING TO SUPERIOR CONSTRUCT. THE BROKEN SHANK REMAINS IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 13481112 ↗InjuryMar 4, 2021Break; Fracture
REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO REMOVE A POLYAXIAL SCREW FROM THE PATIENTS ILIAC. THE SCREW FRACTURE & BROKE AT THE NECK OF THE SHANK.
Patient problems: Failure of Implant
MAUDE report 11416252 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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