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KYPHON® Express ™ Curette A13ARecalls & reported problems

Medtronic Sofamor Danek, Inc. · CURETTE A13A SIZE 2 T-TIP · 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 00643169097223), received between Mar 8, 2019 and Mar 8, 2019 — 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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 8, 2019Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO METASTATIC DISEASE IN SPINE. INTRA-OP, CURRETTE WAS USED BY THE SURGEON TO SCRAP AND SCORE SCLEROTIC BONE, BUT IT HAD STUCK IN PATIENT'S BODY. THE SURGEON HAD WORKED HARD TO GET IT COME OUT OF THE BODY, BUT THE SURGEON FAILED TO REMOVE IT, AND FINALLY USED CANNULA TO PULL IT OUT. TIP OF THE CURRETTE HAS BEEN BROKEN OFF.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8402754 ↗

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Sources and updates

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