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AFT - 1 DIVERTED TUBE

Received Feb 25, 2008 · Event occurred Jan 29, 2008

Report 2249062-2008-00004 · MDR key 1006846

Device

Generic name

Bone Void Filler

Manufacturer

Mtf

Catalog number

227005

Product problems

  • Tip breakage
  • Device, removal of (non-implant)

Patient

Not reported

  • Foreign body, removal of

Narrative

Description of Event or Problem

A FILL TUBE TIP BROKE OFF INSIDE THE MESH DURING A 2-LEVEL FUSION CASE. THE FIRST MESH WAS PLACED AND FILLED AT L5-S1, AND ONLY A SMALL AMOUNT OF GRAFT WAS EXPELLED FROM THE FINAL TUBE. WHEN THE L4-L5 MESH WAS READY FOR FILLING, THAT PARTIAL TUBE WAS INTRODUCED FIRST. WHEN THE DR BEGAN TO EXPEL BONE IN THE MESH THE TIP BROKE. THEY REMOVED THE MESH, THE TUBE AND THE TIP, AND THE BONE AND PLACED A NEW MESH. FILLING WAS COMPLETED WITHOUT A PROBLEM AND IT WAS REPORTED THAT THE DR WAS VERY PLEASED WITH THE OUTCOME.