Invictus® Spinal Cement System 17095-SRecalls & reported problems
Teknimed · Class 2
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 03701505800559), received between Nov 1, 2023 and Nov 1, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2023Migration; Migration
THE INVICTUS SPINAL CEMENT SYSTEM 17095-S LOT 060423095 IS AN ASSEMBLY OF 2 DEVICES: - PUREKIT T060425 LOT 060423014 - INVICTUS BONE CEMENT 17095-1-S LOT 045A23071 SURGEON INTENDED TO USE INVICTUS FENESTRATED SYSTEM WITH INVICTUS SPINAL CEMENT SYSTEM (17095-S) TO AUGMENT FENESTRATED SCREWS IN LUMBAR SPINE TO IMPROVE FIXATION STRENGTH IN OSTEOPOROTIC BONE. USING VISUAL INFORMATION AND A STOPWATCH, THE SPEED OF INJECTION WAS FASTER THAN WHAT IS RECOMMENDED PER THE IFU. OBSERVATIONS SHOW AN INJECTION SPEED OF APPROXIMATELY 1 REVOLUTION PER 2 SECONDS, COMPARED TO THE RECOMMENDED 1 REVOLUTION PER 4 SECONDS. VERBAL INSTRUCTIONS ON INJECTION SPEED WERE GIVEN TO THE SURGEON FROM THE SALES REPRESENTATIVE AND A DEVELOPMENT ENGINEER PRIOR TO THE START OF CEMENT INJECTION, WHICH WAS NOT FOLLOWED. APPROXIMATELY 10 MINUTES AFTER INJECTION OF CEMENT THE PATIENT EXPERIENCED AN EMBOLISM. AFTER PROMPT RESPONSE FROM THE SURGICAL TEAM, THE PATIENT STABILIZED.
Patient problems: Embolism/Embolus
MAUDE report 18052152 ↗
Other Cement, Bone, Vertebroplasty devices
- CONFIDENCE SPINAL CEMENT SYSTEM 283910000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY5 deaths163 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283913000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY8 deaths146 reports
- KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01BMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY3 deaths67 reports
- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705310000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall1 report
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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