DBM PUTTY 5.0CC, AXOGRAFT
Received Sep 14, 2017 · Event occurred Aug 17, 2017
Report 3005168462-2017-00002 · MDR key 6866780
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Bacterin International, Inc.Model number
X090-0015-PT5CCLot number
B110137-DBM
Product problems
- Shelf Life Exceeded
- Shelf Life Exceeded
Patient
40 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PATIENT CONDITION WAS AGAIN VERIFIED ON 09/11/2017 (DATE OF THIS REPORT) AND NO COMPLICATIONS WERE REPORTED.
Description of Event or Problem
ON (B)(4) 2017 BACTERIN WAS NOTIFIED OF AN EXPIRED DBM PUTTY GRAFT IMPLANT. THE GRAFT WAS SOLD AND DISTRIBUTED TO A PRIVATE LABEL DISTRIBUTOR ON 11/02/2015. THE PRIVATE LABEL DISTRIBUTOR SHIPPED THE GRAFT TO THE END-USER FACILITY ON 11/23/2015. THE GRAFT EXPIRED ON 12/03/2016, AND THEN WAS IMPLANTED ON (B)(6) 2017. AT THE TIME OF THIS REPORT THERE WERE NO KNOWN COMPLICATIONS.