KyphPak® First Fracture Tray KEX202EB-CDS-Recalls & reported problems
Medtronic Sofamor Danek, Inc. · KIT KEX202EB-CDS- 20/2 FF WITH CDS · Class 1
Data updated Oct 18, 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 00643169671669), received between Sep 8, 2025 and Sep 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
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.
MalfunctionSep 8, 2025Mechanical Jam; Mechanical Jam
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INFLATABLE BONE TAMP (IBT) WOULD NOT PULL THROUGH THE ACCESS CANNULA AFTER BEING INFLATED IN THE VERTEBRAL BODY. THE PHYSICIAN PULLED NEGATIVE ON THE INFLATOR TO DEFLATE THE BALLOON, TOOK AN IMAGE TO ENSURE CONTRAST HAD BEEN WITHDRAWN, AND ATTEMPTED TO REMOVE THE IBT. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE THROUGH THE OTHER CANNULA AND THEN REMOVED THE CANNULA AND IBT TOGETHER. THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS KYPHOPLASTY. PRODUCT CAME IN CONTACT WITH THE PATIENT. THE EVENT OCCURRED DURING THE PROCEDURE BUT DID NOT PREVENT THE PROCEDURE TO GO FORWARD AS THE DOCTOR MANAGED A WORK-AROUND. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994406 ↗
Other TAMP devices
- KYPHON® Express™ Inflatable Bone Tamp KE152Medtronic Sofamor Danek, Inc. · TAMP35 reports
- KYPHON Express II Inflatable Bone Tamp KE152Medtronic Sofamor Danek, Inc. · TAMP13 reports
- KYPHON Xpander™ II Inflatable Bone Tamp KX203Medtronic Sofamor Danek, Inc. · TAMP11 reports
- KYPHON® Express™ Inflatable Bone Tamp KE102Medtronic Sofamor Danek, Inc. · TAMP10 reports
- KYPHON Xpander™ II Inflatable Bone Tamp KX153Medtronic Sofamor Danek, Inc. · TAMP9 reports
- NA 356.301Synthes GmbH · TAMP6 reports
- KYPHON Xpander II Inflatable Bone Tamp KX203Medtronic Sofamor Danek, Inc. · TAMP6 reports
- RECLAIM 2975-00-675Depuy (Ireland) · TAMP5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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