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ACCELL EVO3 5CC

Received May 31, 2011 · Event occurred May 17, 2011

Report 2090010-2011-00012 · MDR key 2116785

Device

Generic name

Accell

Manufacturer

Integra, Irvine

Catalog number

02-5000-050

Lot number

101010

Product problems

  • Shelf Life Exceeded

Patient

35 YR

  • Injury

Narrative

Additional Manufacturer Narrative

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

Description of Event or Problem

THE REPORTER STATED THAT DURING A LEFT KNEE DISTAL FEMUR OSTEOTOMY SURGICAL PROCEDURE, THE PRODUCT THAT HAD PASSED ITS LABEL EXPIRATION DATE WAS IMPLANTED.