KYPHON Xpander™ II Inflatable Bone Tamp KX103Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE TAMP KX103 10/3 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
- 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 00643169093638), received between Apr 24, 2017 and Apr 24, 2017 — 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 18, 2026.
Most reported problems
Device problems
- Material Rupture2
Patient problems
- 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.
MalfunctionApr 24, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT PATIENT WITH CANCER WITH FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT T7. INTRA-OP, BALLOON RUPTURED DURING INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE SURGERY WAS COMPLETED WITH A NEW PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6515089 ↗MalfunctionApr 24, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT PATIENT WITH CANCER WITH FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT T7. INTRA-OP, BALLOON RUPTURED DURING INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE SURGERY WAS COMPLETED WITH A NEW PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6515088 ↗
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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