AutoPlex, VertaPlex 0605687000Recalls & reported problems
Stryker Corporation · System without Needles with Bone Cement · Class 2
All models of AutoPlex, VertaPlex (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154687169), received between Jan 18, 2019 and Aug 26, 2019 — classified as 2 malfunctions.
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.
Most reported problems
Device problems
- Migration1
- Unsealed Device Packaging1
Patient problems
- Extravasation1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2019Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE DEVICE WAS ALREADY OPENED WHEN THEY WENT TO OPEN IT UP FOR USE. THERE WAS NO PATIENT IMPACT AS THE EVENT WSA NOTICED PRIOR TO THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 8932805 ↗MalfunctionJan 18, 2019Migration; Migration
IT WAS REPORTED BY THE PHYSICIAN THAT THERE WAS DISSATISFACTION WITH THE VISUALIZATION OF THE CEMENT DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE CEMENT LEAKED INTO THE ANTERIOR PORTION OF THE VERTEBRAL BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Extravasation
MAUDE report 8261210 ↗
Other BONE CEMENT devices
- SMARTSET 3122-040Depuy (Ireland) · BONE CEMENT824 reports
- NA 3322-020Depuy (Ireland) · BONE CEMENT306 reports
- NA 3312-040Depuy (Ireland) · BONE CEMENT4 deaths258 reports
- NA 3332-040Depuy (Ireland) · BONE CEMENT4 deaths197 reports
- NA 5450-31-500Depuy (Ireland) · BONE CEMENT2 deaths168 reports
- NA 5450-32-500Depuy (Ireland) · BONE CEMENT1 death150 reports
- PALACOS® MV pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
- PALACOS® R pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 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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