VertaPlex 0406422000Recalls & reported problems
Stryker Corporation · Half Dose Radiopaque Bone Cement · Class 2
- 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 07613327141818), received between Nov 12, 2024 and Nov 12, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Extravasation1
- Hypoxia1
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERGOING PERCUTANEOUS VERTEBROPLASTY (COMPRESSION FRACTURE OF L2 VERTEBRAL BODY TYPE A4 FOLLOWING MVA). CEMENTOPLASTY WITH 2 DOSES OF CEMENT PER PEDICLE UNDER SCOPIC CONTROL TO ENSURE NO LEAKAGE. IN THE ICU, THE PATIENT DESATURATED UP TO 85% IMMEDIATELY POST-EXTUBATION, REQUIRING NIV. PERSISTENT HYPOXEMIA ASSOCIATED WITH TACHYCARDIA PROMPTED ANGIO SCANNING, WHICH REVEALED RIGHT SUBSEGMENTAL CEMENT PULMONARY EMBOLI AND BILATERAL PLEUROPNEUMOPATHY. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMITTED TO THE SURGICAL INTENSIVE CARE UNIT FOR NIV WEANING AND THEN THE PATIENT RETURNED TO INPATIENT WARD FOR FURTHER MANAGEMENT.
Patient problems: Extravasation; Hypoxia; Pulmonary Embolism
MAUDE report 20668393 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.