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

Model Number 359100

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2017

Event Type  malfunction  

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 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
• 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: 6421696
• MDR Text Key: 70765523
• Report Number: 3005168462-2017-00001
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 00849777003681
• UDI-Public: 00849777003681
• 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: 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
• Device Operator: Physician
• Device Expiration Date: 02/08/2017
• Device Model Number: 359100
• Device Lot Number: B110246-DBM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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: 72 YR
• Patient Weight: 55