KYPHON® Cement Delivery System CDS2ARecalls & reported problems
Medtronic Sofamor Danek, Inc. · CEMENT GUN AND BONE FILLER CDS2A SIZE 2 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169463448), received between Aug 13, 2020 and Aug 13, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Prime” (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.
Most reported problems
Device problems
- Failure to Prime1
- Pumping Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2020Failure to Prime; Pumping Problem
AS REPORTED BY STAFF, "THE CEMENT GUN WAS UNABLE TO PUMP CEMENT APPROPRIATELY. ISSUE DISCOVERED ON PRIMING OF GUN. A NEW GUN WAS OPENED AND USED" TO COMPLETE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10401071 ↗
Other DISPENSER, CEMENT devices
- SMARTSET 3102-080Depuy (Ireland) · DISPENSER, CEMENT75 reports
- Medtronic Reusable Instrument 6550202Medtronic Sofamor Danek, Inc. · DISPENSER, CEMENT2 deaths59 reports
- KYPHON® Express™ Directional Bone Filler Device F06BMedtronic Sofamor Danek, Inc. · DISPENSER, CEMENT1 recall1 report
- EXPEDIUM 279726500Medos International Sàrl · DISPENSER, CEMENT44 reports
- Revolution 0606600000Stryker Corporation · DISPENSER, CEMENT33 reports
- n/a 6550041Medtronic Sofamor Danek, Inc. · DISPENSER, CEMENT16 reports
- NA 0606100000Stryker Corporation · DISPENSER, CEMENT15 reports
- NA 0206600000Stryker Corporation · DISPENSER, CEMENT14 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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