Kyphon V Premium Vertebroplasty VPB13Recalls & reported problems
Medtronic Sofamor Danek, Inc. · VP 15GA BIOPSY VPB13 BIOPSY /TAMP · 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 00763000026752), received between Jun 10, 2021 and Jun 10, 2021 — classified as 1 malfunction.
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.
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.
MalfunctionJun 10, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN INDICATION FOR SPINAL THERAPY IT WAS REPORTED THAT HANDLE TORE OFF AND JUST THE CANULA WAS STICKING OUT OFTHE BACK. IT TOOK 30 MINUTES TO GET IT OUT. THE BONE WAS HARD. WITH NO HANDLE THERE WAS NOTHING TO GRAB ON TO. FINALLY IT WAS OUT WITH THE HELP OF SOME ROD HOLDERS AND PLYERS . THE PRODUCT CAME IN PATIENT CONTACT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11972949 ↗
Other DEVICE, PERCUTANEOUS, BIOPSY devices
- Cook G00012Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall2 reports
- Cook G00013Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00852Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G05040Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00850Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G03978Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G03314Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G01559Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 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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