SOLUTION SYSTEM 2108-50-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION SYSTEM FEMORAL GRAFT TAMP - STRAIGHT 22mm DIA · Class 1
Data updated Oct 13, 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 10603295087229), received between Apr 26, 2021 and Sep 24, 2021 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Failure to Cut1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2021Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TAMP WAS NO LONGER FLAT. IT WAS WORN DOWN TO THE POINT OF NOT BEING USABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12527326 ↗MalfunctionApr 26, 2021Break; Break
IT WAS REPORTED THAT THE CHIPPED/DAMAGED FOUND ONE RETURNED TO THE OFFICE .NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11724632 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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