KYPHON LATITUDE II Curette A11ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000031923), received between Jun 21, 2021 and Jun 21, 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

Recent adverse event reports

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

• MalfunctionJun 21, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT USING A CURETTE FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT WHEN THE DR. INSERTED THE CURETTE INTO THE VERTEBRAL BODY AND PULLED THE TRIGGER TO DEPLOY THE TIP, IT BROKE. THE BONE WAS NOT CONSIDERED HARD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS VCF AND LEVELS IMPLANTED WERE L1. THERE WAS A DELAY OF 5 MINUTES IN OVERALL PROCEDURE TIME. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED / IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THE PRODUCT WILL BE REPLACED BY A MEDTRONIC PRODUCT IN THE FUTURE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030798 ↗