SUBTALAR MBA IMPLANT 14MM
Received Aug 19, 2011 · Event occurred Jul 1, 2011
Report 3004608878-2011-00120 · MDR key 2249625
Device
Product problems
- Shelf Life Exceeded
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE REPORTER STATED THAT THE USER FACILITY IMPLANTED TWO EXPIRED DEVICES ON (B)(6) 2011. THE PRODUCTS EXPIRED ON (B)(6) 2011. THE PATIENT WAS ANESTHETIZED AND IN THE OPERATING ROOM. HE NEEDED SIZE 14MM IMPLANTS. INTEGRA NO LONGER MARKET THIS SIZE IMPLANT. THE USER FACILITY ELECTED TO STERILE PROCESS THE DEVICES USING JOINT COMMISSION GUIDELINES. THE PRODUCTS WERE PURCHASED BY THE HOSPITAL ON 11/24/2006, THEREFORE, INVENTORY HAS BEEN IN THE POSSESSION OF THE HOSPITAL FOR ALMOST 5 YEARS. THE INTEGRA DISTRIBUTOR WAS NOT PRESENT AT THE SURGERY.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.