13 Ga Tamp VPT02ARecalls & reported problems
Medtronic Sofamor Danek, Inc. · TOOLKIT VPT02A VP NEEDLE SET CURV 13 GA · 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 00763000311834), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
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 21, 2021Material Separation; Material Separation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHILE INJECTING XPEDE CEMENT WITH CDS GUN THRU KURVE BONE FILLER DEVICE THE PURPLE HUB (WHERE CEMENT CARTRIDGE IS ATTACHED) POPPED OFF/SEPARATED FROM METAL PORTION OF KURVE BONE FILLER DEVICE. THERE WAS CEMENT IN THE KURVE BONE FILLER DEVICE AS WELL. DR (B)(6) THEN USED FORCEPS TO REMOVE CANNULA AND KURVE BONE FILLER DEVICE FROM PATIENT. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12504052 ↗
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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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