MAUDE Adverse Event Report: BACTERIN INTERNATIONAL, INC. OSTEOSELECT; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number	359100
Medical Device Problem Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company was notified on 02/24/2017 that an expired product was implanted into a patient on (b)(6) 2017.The product's expiration date was 02/08/2017.The hospital was notified by the company on 02/20/2017 that they had an expired graft in inventory.Subsequent communication with the hospital on 03/10/2017, revealed that an employee absence could have contributed to the incident despite the notification from the company.Patient discharged on (b)(6) 2017 with no known complications.Device implanted, not returned for eval.
Event or Problem Description
The company was notified on 02/24/2017 that an expired product was implanted into a patient on (b)(6) 2017.The product's expiration date was 02/08/2017.The hospital was notified by the company on 02/20/2017 that they had an expired graft in inventory.Subsequent communication with the hospital on 03/10/2017, revealed that an employee absence could have contributed to the incident despite the notification from the company.Patient discharged on (b)(6) 2017 with no known complications.

• Brand Name: OSTEOSELECT
• 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: 6421696
• Report Number: 3005168462-2017-00001
• Device Sequence Number: 317110
• Product Code: MBP
• UDI-Device Identifier: 00849777003681
• UDI-Public: 00849777003681
• 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): 03/20/2017

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: 02/08/2017
• Device Model Number: 359100
• Device Lot Number: B110246-DBM
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 55