KYPHON Express Curette A13ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000031848), received between Dec 17, 2020 and Feb 18, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINOPL ASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE (COMPRESSION FRACTURE). IT WAS REPORTED THAT BALLOON WAS RUPTURED DURING EXPANSION AND CURETTE COULD NOT CHANGE THE ANGLE DUE TO WIRE BREAKAGE. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED DURING NORMAL USAGE OF PRODUCTS AND NO MANUFACTURING ISSUE SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397789 ↗
• MalfunctionJun 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE CURETTE SHAFT BENT AND BROKE WITHOUT THE CLUTCH ENGAGING TO PREVENT SUCH DAMAGE. THE DAMAGE LOOKS PROXIMAL TO THE ARTICULATION POINT. THERE WERE NO PATIENT SYMPTOMS REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO FRAGMENTS LEFT INSIDE THE PATIENT. PROCEDURE INVOLVED WAS KYPHOPLASTY AND PREOP DIAGNOSIS WAS VERTEBRAL COMPRESSION FRACTURE (VCF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482549 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1 SPINAL THERAPY FOR AN INDICATION OF PAINFUL METASTATIC SPINE TUMORS. IT WAS REPORTED THAT THE BONE INSIDE THE L1 VERTEBRAE WAS EXTREMELY SCLEROTIC AND THE TIP OF THE INSTRUMENT SEPARATED FROM THE REST OF THE DEVICE AND REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14768035 ↗
• MalfunctionApr 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A CURETTE IN A BALLOON KYPHOPLASTY (BKP) FOR A VERTEBRAL COMPRESSION FRACTURE AT T11. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON ENCOUNTERED VERY HARD BONE. SHE ATTEMPTED TO INFLATE THE BALLOONS, BUT THEY HAD AN ABNORMAL INFLATION SHAPE AS WELL AS VERY HIGH BALLOON PRESSURES. SHE REMOVED THE BALLOONS AND INSERTED A CURETTE ENGAGED AT 90°. SHE GAVE IT ONE TURN AND IT IMMEDIATELY BROKE AT THE TIP. SHE REMOVED IT AND IT WAS OBVIOUSLY BROKEN ALONG THE END OF THE METAL SHAFT, BUT THE TIP REMAINED ATTACHED VIA THE TETHER. THEY RETRIEVED A NEW CURETTE AND HAD NO ISSUES USING THAT ONE. THE REST OF THE PROCEDURE CONTINUED AS EXPECTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO A DELAY IN OVERALL PROCEDURE TIME, NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY, AND NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14082446 ↗
• MalfunctionOct 8, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING UNKNOWN SPINAL THERAPY. THE PRE-OP DIAGNOSIS WAS MENTIONED AS VCF AND PAINFUL METASTATIC LESION. IT WAS REPORTED THAT, DISTAL TIP OF CURETTE BROKE OFF IN MIDDLE OF PATIENT VERTEBRAL BODY. THE LEVELS IMPLANTED WERE MENTIONED AS L2. NO HEALTH DAMAGE IN PATIENT WAS REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PLANNED OR PERFORMED TO RETRIEVE THE BROKEN FRAGMENT LEFT IN PATIENT. THERE WAS NO TIME DELAY REPORTED AS A RESULT OF PRODUCT MALFUNCTION. THERE WERE NO SYMPTOMS TO PATIENT REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED TO PATIENT AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12597585 ↗
• MalfunctionJan 13, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF VERTEBRAL COMPRESSION FRACTURE, UNDERGOING A SPINAL THERAPY. IT WAS REPORTED THAT THE PHYSICIAN USED CURETTE DUE TO VERY SCLEROTIC BONE. BONE WAS SO HARD, CURETTE WOULD NOT DEPLOY. HE TAPPED ON CURETTE WITH MALLET TO ADVANCE AND HELP DEPLOY CURETTE TO 90 DEGREE. ROTATED IN A CIRCULAR MOTION TO SCORE BONE. CURETTE SAFETY BREAKAWAY HAPPENED SEVERAL TIMES DUE TO HARD BONE. THEN A SMALL SNAP WAS HEARD WHEN SAFETY BREAKAWAY WAS HEARD THE LAST TIME. THEN HE PULLED OUT THE BROKEN CURETTE AFTER A SATISFACTORY SCORING. A VERY TINY PIECE OF METAL DEBRIS SEEMED TO BE IN THE SCORE VOID BUT WAS NOT VERIFIED AS IT WAS JUST A SPEC ON THE SCREEN. PHYSICIAN INSPECTED THE CURETTE AND DID NOT SEE ANYTHING MISSING FROM THE CURETTE. HE FINISHED BY CEMENTING THE ENTIRE VERTEBRAE. NO SPEC WAS ABLE TO BE SEEN WITH INTRA OP FINAL IMAGES. PHYSICIAN STATED THAT HE WAS PLEASED WITH THE COMPLETE FULL FILL OF CEMENT IN VERTEBRAE AND SATISFACTORY COMPLETION OF THE PROCEDURE. PATIENT WOKE UP WITH SOME PAIN RELIEF POST OP. PHYSICIAN STATED THAT THE AFRICAN AMERICAN BONE WAS EXTREMELY HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11160028 ↗
• MalfunctionDec 17, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR AN UNK NOWN SPINAL THERAPY. IT WAS REPORTED THAT, THE CURETTE WAS DEFECTIVE. IT WAS MENTIONED THAT WHILE UTILIZING THE CURETTE ANTERIORLY IN VERTEBRAL BODY AT T9, INSTRUMENT WAS BROKE. IT WAS MENTIONED THAT THE PRODUCT WAS USED AS DIRECTED BUT WHEN THE TRIGGER OF THE GUN WOULD NOT COLLAPSE AND THE WHOLE HANDLE FELL APART. THE CURETTE WAS REMOVED FROM THE CANNULA, THE BROKEN TIP WAS ATTACHED BY A WIRE AND EVERYTHING WAS RETRIEVED. IT WAS MENTIONED THAT THERE WAS NO FOREIGN MATERIAL LEFT IN THE PATIENT. THERE WAS AN UNSPECIFIED DELAY WAS REPORTED AS A RESULT OF THIS EVENT. THE PRE-OPERATIVE DIAGNOSIS OF THE PATIENT WAS MENTIONED AS T9 VERTEBRAL BODY FRACTURE. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 2020-DEC-01: IT WAS REPORTED THAT THERE WAS A DELAY OF 2 MINUTES AS A RESULT OF THIS EVENT. THERAPY INVOLVED DURING THIS EVENT WAS MENTIONED AS BALLOON KYPHOPLASTY. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11026889 ↗