KYPHON® ELEMENT™ KR153 (UDI 00643169582217)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INFLATABLE BONE TAMP KR153 15MM VALUEIBT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169582217), received between Oct 6, 2020 and Oct 7, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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
Device problems
- Material Rupture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2020Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, WHEN BIPOLAR CANNULAS WERE PLACED ALONG WITH BALLOONS TO INSULATE THEM AND PREPARE CAVITIES FOR PLACEMENT OF BONE CEMENT, THE BALLOONS RUPTURED INSIDE THE VERTEBRAL BODY. THIRD BALLOON WAS PLACED AND IT ALSO BROKE. THERE WERE NO PIECES OF METAL FROM CANNULA THAT COULD BREAK THE FOLLOWING BALLOON AND ALL THE PROCEDURE WAS CARRIED OUT BY PRESCRIBED TECHNIQUE. THERE WERE NO PATIENT INJURY REPORTED AS A RESULT OF THE EVENT. FURTHER THERE WERE NO PATIENT SYMPTOMS, OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10641164 ↗MalfunctionOct 6, 2020Break; Material Rupture; Break; Material Rupture
ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THE T25R NEEDLE BENT AND THE BALLOON BURST INSIDE THE VERTEBRAL BODY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PRE-OP DIAGNOSIS: PROBLEM IN THE VERTEBRAL POSTURE. PROCEDURE INVOLVED: BILATERAL KYPHOPLASTY WITH BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10633099 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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