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AFT STRAIGHT TUBE (1/2 FILLED)

Received Aug 3, 2011 · Event occurred Jul 1, 2011

Report 2249062-2011-00003 · MDR key 2210094

Device

Generic name

Bone Void Filler

Manufacturer

Mtf

Catalog number

227010

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Fluid Discharge

Narrative

Description of Event or Problem

ON (B)(6) 2011, THE PT UNDERWENT SURGERY AND WAS IMPLANTED WITH A UNIT OF AFT. ON (B)(6) 2011, THE PT RETURNED TO THE OPERATING ROOM BECAUSE OF DRAINAGE AT THE INCISION SITE. CULTURES WERE OBTAINED; THE RESULTS ARE PENDING. THE PT HAS UNDERGONE TWO IRRIGATION AND DEBRIDEMENT (I & D) PROCEDURES. THE REPORTER COULD NOT CONFIRM RECORD OF ANTIBIOTIC TREATMENT. CURRENT STATUS OF THE PT IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED; NOT YET RECEIVED. SEE MEDWATCH # 2249062-2011-00001.