KYPHON® ELEMENT™ KR153 (UDI 00763000025823)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000025823), received between Nov 17, 2021 and Dec 1, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THE KR153 BALLOON WAS RUPTURED AND COULD NOT BE USED NORMALLY. THE PRODUCT WAS REPLACED WITH A NEW KR153 IN THE HOSPITAL TO COMPLETE THE OPERATION. ON 2021-NOV-17: RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907467 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  ADDITIONAL INFORMATION RECEIVED. IT WAS UNKNOWN, IF THERE WAS ANY RUPTURED FRAGMENTS LEFT INSIDE PATIENT BODY. NO SYMPTOMS TO PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907382 ↗
• MalfunctionNov 22, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE BALLOON WAS FOUND TO BE RUPTURED AND COULD NOT BE USED NORMALLY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850600 ↗
• MalfunctionNov 17, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HOTLINE VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPIN AL PROCEDURE. IT WAS REPORTED THAT TWO BALLOONS HAD RUPTURED AND COULD NOT BE USED NORMALLY. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION. THERE WAS NO LEAKAGE INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825865 ↗