EXPEDIUM 279755602Recalls & reported problems
Medos International Sàrl · EXPEDIUM OSTEOTOMY SET NARROW POSTERIOR TAMP 25mm · Class 1
- 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 10705034472829), received between May 14, 2019 and Oct 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS BROKEN TIP. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20472797 ↗MalfunctionMay 14, 2019Break; Break
THE SURGEON WAS USING THE VERTEBRAL BODY TAMP FROM THE EXPEDIUM OSTEOTOMY SET AS IT WAS INTENDED. HE WAS MALLETING ON THE BACK OF THE INSTRUMENT WHILE THE FOOTED TAMP WAS SNUGGLE PLACED IN BETWEEN THE SPINAL CORD AND POSTERIOR WALL OF THE L4 VERTEBRAL BODY. WHILE MALLETING, THE FOOTED PORTION TO THE 25MM TAMP BROKE INSITU. FORTUNATELY, THE PATIENT WAS NOT HARMED DURING THIS FAILURE AND THE BROKEN INSTRUMENT FRAGMENT WAS RECOVERED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8607492 ↗
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
- KYPHON Xpander II Inflatable Bone Tamp KX203Medtronic Sofamor Danek, Inc. · TAMP6 reports
- NA 356.301Synthes GmbH · TAMP6 reports
- KyphPak® First Fracture Tray KEX102EB-CDS-Medtronic Sofamor Danek, Inc. · TAMP5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.