KYPHON LATITUDE II Curette A11DRecalls & reported problems
Medtronic Sofamor Danek, Inc. · CURETTE A11D KYPHX LATITUDE II WEDG TIP · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000031916), received between Apr 26, 2021 and Apr 26, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2021Break; Break
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THE PROCEDURE INVOLVED WAS BALLOON KYPHOPLASTY. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11722632 ↗MalfunctionApr 26, 2021Break; Break
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THE PROCEDURE INVOLVED WAS BALLOON KYPHOPLASTY. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11722627 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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