KYPHON LATITUDE II Curette A11BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000031909), received between Oct 27, 2019 and May 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A CURETTE USED IN BKP FOR VERTE BRAL FRACTURE. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT IT BROKE JUST BY GRIPPING THE CURETTE TWICE DURING THE PROCEDURE. THERE WAS NO PATIENT SYMPTOM REPORTED. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14302384 ↗
• MalfunctionDec 28, 2021Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091784 ↗
• MalfunctionNov 29, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A CURETTE IN A BKP FOR A COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE CURETTE HANDLE AND TIP NO LONGER INTERLOCK. THE TIP BECAME IMMOBILE FROM THE MIDDLE. WHEN CHECKING THE CURETTE, IT SEEMED THAT THE PRODUCT WAS SEPARATED AT THE NOTCH PART. IT IS UNKNOWN IF THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12880405 ↗
• MalfunctionOct 27, 2019Break; Mechanical Problem; Break; Mechanical Problem

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, AFTER THE CURETTE WAS INSERTED INTO THE VERTEBRAL BODY, THE ANGLE DID NOT CHANGE EVEN WHEN THE LEVER WAS GRASPED. THE CURETTE WAS BEING USED IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE TIP OF THE CURETTE DID NOT MOVE EVEN WHEN THE SURGEON WAS CHECKING OUTSIDE THE PATIENT¿S BODY. HENCE, ANOTHER CURETTE WAS OPENED AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. WHEN THE CURETTE WAS CHECKED, IT WAS FOUND THAT A PART OF THE CURETTE HAD SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9243341 ↗