KYPHON® Cement Delivery System CDS3ARecalls & reported problems
Medtronic Sofamor Danek, Inc. · CEMENT GUN AND BONE FILLER CDS3A SIZE 3 · Class 1
Data updated Oct 16, 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 00643169463455), received between Mar 30, 2022 and Mar 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Inflation Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2022Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Inflation Problem; Leak/Splash; Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS L1 FX. IT WAS REPORTED THAT T15S WAS USED TO ACCESS THE L1 VERTEBRAL BODY ON RIGHT PEDICLE UNTIL SHY ANTERIOR WALL PER LABELING. THE TROCAR WAS REMOVED AND BALLOON WAS INSERTED. BALLOON INFLATED ONLY SLIGHTLY DESPITE BEING VERY HIGH PRESSURE (>400 PSI). FIRST PACK OF XPEDE CEMENT WAS MIXED FOR 20 SECONDS UNTIL SLIGHTLY UNDER DOUGHY AND CDS CARTRIDGES WERE FILLED. THE BONE FILLED WAS PRIMED WITH THE CDS GUN AND CEMENT WAS JUST UNDER DOUGHY AND INSERTED INTO CANNULA TO THE ANTERIOR PORTION OF L1. IMMEDIATELY NOTED THERE WAS HIGH PRESSURE AS BONE FILLER KEPT POPPING OUT OF THE LOCKING MECHANISM ON CANNULA AND FILL WAS ONLY AT THE LATERAL AND POSTERIOR WALL DESPITE PHYSICIAN HOLDING THE BONE FILLER IN PLACE. THE CDS GUN STARTS LEAKING RIGHT AWAY. HE RETHREADS THE CDS GUN BUT STILL HAS TROUBLE WITH LEAKING. EVENTUALLY STOPS WORKING SO WE USE A FRESH BONE FILLER AND FRESH CDS CARTRIDGE. STILL HAVING THE SAME ISSUE WITH LEAKING AND CDS GUN NOT PUSHING THE CEMENT INTO BODY. HE REMIXES THE ANOTHER BACK OF XPEDE CE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13950130 ↗
Other DISPENSER, CEMENT devices
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- 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 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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