KYPHON Xpander II KyphoPak Tray KPX103RBRecalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE TAMP KIT KPX103RB FF X2 10/3 OIS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000031558), received between Jan 3, 2022 and Jan 3, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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 Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2022Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH VERTEBRA FRACTURE. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN FILLED WITH CONTRAST. AFTER THE BALLOON RUPTURE, ANOTHER KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT SYMPTOM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13140995 ↗
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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