KYPHON Xpander II Inflatable Bone Tamp KX153Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE TAMP KX153 15/3 XPANDER II IBT · Class 1
All models of KYPHON Xpander II Inflatable Bone Tamp (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000025717), received between Jun 13, 2019 and Nov 26, 2020 — classified as 3 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 18, 2026.
Most reported problems
Device problems
- Material Rupture2
- Material Split, Cut or Torn1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2020Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE (VCF) SUGGESTED FOR SPINAL THERAPY. LEVEL IMPLANTED WAS L3. EVENT OCCURRED INTRA-OP. IT WAS REPORTED BALLOON WAS INSERTED , PRESSURE REACHED NEAR 400 PSI , BALLOON RUPTURED DURING INFLATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED. UPDATE; PROCEDURE/THERAPY USED ¿ BALLOON KYPHOPLASTY; IBT ISSUE WAS IT BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10910695 ↗MalfunctionJul 12, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY AT L4-L5 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, THE BALLOON RUPTURED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8783818 ↗MalfunctionJun 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE; AND UNDERWENT VERTEBRAL AUGMENTATION. INTRA-OP, DISTAL END OF STYLET PROTRUDED FROM BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME PRODUCT; HOWEVER, THE PROCEDURE TIME WAS DELAYED FOR ABOUT 3 MINUTES TO INSPECT THE STYLET. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8697052 ↗
Other TAMP devices
- KYPHON® Express™ Inflatable Bone Tamp KE152Medtronic Sofamor Danek, Inc. · TAMP35 reports
- KYPHON Express II Inflatable Bone Tamp KE152Medtronic Sofamor Danek, Inc. · TAMP13 reports
- KYPHON Xpander™ II Inflatable Bone Tamp KX203Medtronic Sofamor Danek, Inc. · TAMP11 reports
- KYPHON® Express™ Inflatable Bone Tamp KE102Medtronic Sofamor Danek, Inc. · TAMP10 reports
- KYPHON Xpander™ II Inflatable Bone Tamp KX153Medtronic Sofamor Danek, Inc. · TAMP9 reports
- NA 356.301Synthes GmbH · TAMP6 reports
- KYPHON Xpander II Inflatable Bone Tamp KX203Medtronic Sofamor Danek, Inc. · TAMP6 reports
- RECLAIM 2975-00-675Depuy (Ireland) · TAMP5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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