Invictus 15295-55-080Recalls & reported problems
Alphatec Spine, Inc. · Ti, MIS Lordotic Rod, VI2, 5.5mm X 80mm · Class 2 · Implant
All models of Invictus (96)
Data updated Oct 16, 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 00190376269719), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2024. APPROXIMATELY TWO AND A HALF MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED THAT THE ROD ON THE RIGHT SIDE OF THE CONSTRUCT HAD COMPLETELY DISENGAGED FROM THE TULIP HEAD, AND THE INTERBODY IMPLANT HAD ROTATED WITHIN THE DISC SPACE. DURING REVISION SURGERY, EXPOSURE OF THE ORIGINAL CONSTRUCT REVEALED ALL SET SCREWS WERE INTACT AND SECURE ON THE ROD EXCEPT FOR THE RIGHT L4 SCREW. ALTHOUGH THE SET SCREW REMAINED SEATED WITHIN THE TULIP HEAD, THE ROD HAD MIGRATED OUT OF POSITION. BOTH RODS WERE SUBSEQUENTLY REMOVED AND REPLACED, ALONG WITH THE SCREWS AT L4 AND L2. ALL SET SCREWS WERE ALSO REMOVED AND REPLACED. PRIOR TO FINAL TIGHTENING, THE INTERBODY IMPLANT WAS REPOSITIONED. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 21939559 ↗
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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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