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

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The patient condition was again verified on 09/11/2017 (date of this report) and no complications were reported.

Event 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
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): BACTERIN INTERNATIONAL, INC.; 600 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): BACTERIN INTERNATIONAL, INC.; 600 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 600 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 6866780
• MDR Text Key: 86515552
• Report Number: 3005168462-2017-00002
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 00849777005661
• UDI-Public: 00849777005661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 12/03/2016
• Device Model Number: X090-0015-PT5CC
• Device Lot Number: B110137-DBM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2017
• Device Age: 4 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR