KYPHON® EXPRESS™ Bone Biopsy Device F07ARecalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE BIOPSY DEVICE F07A TAPERED SIZE 2 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00763000311704), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
InjuryJun 5, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A KYPHON EXPRESS BONE BIOPSY DEV ICE USED FOR LUMBAR 4 BONE BIOPSY IN INTERVENTIONAL RADIOLOGY. IT WAS REPORTED THAT PATIENT UNDERGOING LUMBAR 4 BONE BIOPSY UTILIZING MEDTRONIC KYPHON EXPRESS BONE BIOPSY DEVICE (SIZE 2) IN INTERVENTIONAL RADIOLOGY. DURING REMOVAL, INNER BIOPSY NEEDLE (13-GAUGE JAMSHIDI NEEDLE) BROKE OFF INSIDE OF PATIENT'S L4 REGION. MULTIPLE ATTEMPTS TO RETRIEVE RETAINED NEEDLE FRAGMENT WERE UNSUCCESSFUL. NE UROSURGERY CONTACTED AND PATIENT TAKEN TO OR (OPERATING ROOM) FOR SURGICAL REMOVAL OF RETAINED NEEDLE. DURING OR PROCEDURE, NEEDLE CONTINUED TO CRUSH AND FRACTURE WHEN ATTEMPTING TO REMOVE. INITIAL INCISION WAS WIDENED, AND MICROSURGICAL TECHNIQUE UTILIZING THE OP ERATIVE MICROSCOPE TO SUCCESSFULLY REMOVE THE REMAINDER OF THE RETAINED NEEDLE. DURING IR (INTERVENTIONAL RADIOLOGY) AND OR (OPERATING ROOM) PROCEDURES BONE NOTED TO BE SCLEROTIC. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153373 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page