BIO DBM PUTTY 10CC
Received Apr 26, 2017 · Event occurred Apr 18, 2017
Report 3004024955-2017-00018 · MDR key 6522682
Device
Generic name
Resorbable Calcium Salt Bone Void Filler Device
Manufacturer
Stryker Spine-usModel number
7775010Catalog number
7775010
Lot number
1571706528
Product problems
- Device Damaged Prior to Receipt by User
- Adverse Event Without Identified Device or Use Problem
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT; DR. BOOKED LUMBAR FUSION AND SAID MUST USED DBM PUTTY. WE ORDERED DBM PUTTY LAST WEEK FOR CASE BUT THE 10CC PUTTY WE ORDERED WAS ON B/O SO WE DIDN'T RECEIVE THAT. WE HAD 20CC TOTAL (5CC SIZE), SO AS A BACK UP WE HAD A COURIER BRING 10CC PUTTY FROM (B)(6) THE MORNING OF (B)(6) 2017. AS THE CASE WENT ON WE OPENED ALL 5CC SIZES AND DR. SAID HE NEEDED MORE SO THEN THE BORROWED 10CC WAS OPENED FOR CASE. THIS WAS DONE SO BEFORE THE HOSPITAL COULD INPUT THE PRODUCT IN THEIR SYSTEM. LATER ON IN DAY WE GOT A CALL FROM HOSPITAL ASKING WHERE WE GOT THE DBM FROM. REP EXPLAINED HOW WE GOT THE PRODUCT, THAT A PIECE OF TISSUE WAS TRANSFERRED FROM ONE HOSPITAL TO ANOTHER.
Description of Event or Problem
IT WAS REPORTED THAT; DR. (B)(6) LUMBAR FUSION AND SAID MUST USED DBM PUTTY. WE ORDERED DBM PUTTY LAST WEEK FOR CASE BUT THE 10CC PUTTY WE ORDERED WAS ON B/O SO WE DIDN'T RECEIVE THAT. WE HAD 20CC TOTAL (5CC SIZE), SO AS A BACK UP WE HAD A COURIER BRING 10CC PUTTY FROM (B)(6) THE MORNING OF (B)(6) 2017. AS THE CASE WENT ON WE OPENED ALL 5CC SIZES AND DR. SAID HE NEEDED MORE SO THEN THE BORROWED 10CC WAS OPENED FOR CASE. THIS WAS DONE SO BEFORE THE HOSPITAL COULD INPUT THE PRODUCT IN THEIR SYSTEM. LATER ON IN DAY WE GOT A CALL FROM HOSPITAL ASKING WHERE WE GOT THE DBM FROM. REP EXPLAINED HOW WE GOT THE PRODUCT, THAT A PIECE OF TISSUE WAS TRANSFERRED FROM ONE HOSPITAL TO ANOTHER.