BIO DBM PUTTY 1CC
Received Oct 27, 2016 · Event occurred Oct 18, 2016
Report 3004024955-2016-00097 · MDR key 6062016
Device
Generic name
Resorbable Calcium Salt Bone Void Filler Device
Manufacturer
Stryker Spine-usCatalog number
7775001
Lot number
1535846547
Product problems
- Device Expiration Issue
Patient
74 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT; DURING A ONE LEVEL MIS TLIF CASE WITH DOCTOR, HE REQUESTED A 2 OR 3 CC 'S OF DBM AVAILABLE TO MIX WITH HIS AUTOGRAFT SO AS THE CASE BEGAN FOUR BOXES OF 1 CC BIO DBM WERE BROUGHT FROM WHERE IT IS STORED AT THE HOSPITAL. WE GOT TO THE POINT WHERE WE NEEDED TO OPEN GRAFT AND TWO 1CC BIO DBM GRAFTS WERE REQUESTED TO OPEN TO THE FIELD. RANDOMLY GRABBED TWO BOXES OUT OF THE FOUR IN THE ROOM AND HANDED THEM TO CIRCULATOR TO OPEN. I THEN LEFT THE ROOM TO GO GRAB CAGES TO BRING IN. BY THE TIME I GOT BACK THE GRAFT WAS OPEN AND ON THE FIELD. I PUT STICKERS ON MY CHARGE SHEET AND CONTINUED WITH THE CASE. I DID NOT OPEN, OR LOG INTO THE HOSPITAL TISSUE TRACKING BOOK ANY OF THE TRACKING INFORMATION. I WAS NOTIFIED THAT ONE OF THE GRAFTS WE USED WAS EXPIRED ON 9/15/16.
Additional Manufacturer Narrative
METHOD: DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESMENT; RESULT: IT WAS CONFIRMED THAT THE PRODUCT WAS IMPLANTED INTO A PATIENT PAST IT'S EXPIRATION DATE. IT WAS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: IT IS UNKNOWN HOW THIS OCCURRED. IT IS POSSIBLE THE HOSPITAL STAFF MOVED IT, BUT THIS CANNOT BE CONFIRMED OR DENIED.
Description of Event or Problem
IT WAS REPORTED THAT; DURING A ONE LEVEL MIS TLIF CASE WITH DOCTOR, HE REQUESTED A 2 OR 3 CC 'S OF DBM AVAILABLE TO MIX WITH HIS AUTOGRAFT SO AS THE CASE BEGAN FOUR BOXES OF 1 CC BIO DBM WERE BROUGHT FROM WHERE IT IS STORED AT THE HOSPITAL. WE GOT TO THE POINT WHERE WE NEEDED TO OPEN GRAFT AND TWO 1CC BIO DBM GRAFTS WERE REQUESTED TO OPEN TO THE FIELD. RANDOMLY GRABBED TWO BOXES OUT OF THE FOUR IN THE ROOM AND HANDED THEM TO CIRCULATOR TO OPEN. I THEN LEFT THE ROOM TO GO GRAB CAGES TO BRING IN. BY THE TIME I GOT BACK THE GRAFT WAS OPEN AND ON THE FIELD. I PUT STICKERS ON MY CHARGE SHEET AND CONTINUED WITH THE CASE. I DID NOT OPEN, OR LOG INTO THE HOSPITAL TISSUE TRACKING BOOK ANY OF THE TRACKING INFORMATION. I WAS NOTIFIED THAT ONE OF THE GRAFTS WE USED WAS EXPIRED ON 9/15/16.