NA 359.205Recalls & reported problems
Synthes GmbH · TAMP/STANDARD · Class 1
Data updated Oct 16, 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 10886982197061), received between Jun 28, 2023 and Jun 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionJun 28, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE TAMP/STANDARD. THIS IS REPORT 6 OF 7 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17216718 ↗
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
- KyphPak® First Fracture Tray KEX102EB-CDS-Medtronic Sofamor Danek, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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