NA 356.302Recalls & reported problems
Synthes GmbH · 30 DEG TAMP · Class 1
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 10886982195326), received between Jul 12, 2022 and Mar 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack2
- Break1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE 6 CRACKS OR BREAKAGES WERE NOTED ON THE Y CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARS IN THE MIDDLE OF THE Y.
Patient problems: Insufficient Information
MAUDE report 21530002 ↗MalfunctionJul 12, 2022Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TAMP WAS UNABLE TO BE ASSEMBLED AND STERILIZED, AS IT WAS CHIPPING AND CRACKING. THERE IS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR A 30 DEG TAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14988983 ↗
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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