MAUDE Adverse Event Report: BACTERIN INTERNATIONAL, INC. DBM PUTTY 5.0CC, AXOGRAFT; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number	X090-0015-PT5CC
Medical Device Problem Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient condition was again verified on 09/11/2017 (date of this report) and no complications were reported.
Event or Problem Description
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.

• Brand Name: DBM PUTTY 5.0CC, AXOGRAFT
• Common Device Name: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): BACTERIN INTERNATIONAL, INC.; 600 cruiser lane; belgrade MT 59714
• MDR Report Key: 6866780
• Report Number: 3005168462-2017-00002
• Device Sequence Number: 1364485
• Product Code: MBP
• UDI-Device Identifier: 00849777005661
• UDI-Public: 00849777005661
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K130498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/03/2016
• Device Model Number: X090-0015-PT5CC
• Device Lot Number: B110137-DBM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2017
• Device Age: 4 YR
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR