OSTEOSELECT
Received Mar 21, 2017 · Event occurred Feb 23, 2017
Report 3005168462-2017-00001 · MDR key 6421696
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Bacterin International, Inc.Model number
359100Lot number
B110246-DBM
Product problems
- Shelf Life Exceeded
- Shelf Life Exceeded
Patient
72 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS. DEVICE IMPLANTED, NOT RETURNED FOR EVAL.
Description of Event or Problem
THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS.