IVAS 1021315000Recalls & reported problems
Stryker Corporation · Inflatable Vertebral Augmentation System · Class 2
All models of iVAS (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327374469), received between Oct 10, 2018 and Oct 10, 2018 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE SALES REP THAT THE KYPHOPLASTY PROCEDURE WAS COMPLETED SUCCESSFULLY BUT THAT TWO DAYS LATER, THE PATIENT PASSED AWAY.
Patient problems: Death
MAUDE report 7951484 ↗
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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