MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION OSTEOSURGE 300; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number SSU-16-07241

Device Problem Use of Device Problem (1670)

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

Event Date 09/29/2016

Event Type  malfunction  

Event Description

Patient was implanted with bone putty that the vendor provided.The operating room staff, nor the vendor follow the tissue policies / protocols.There is no storage or temperature documentation related to the implanted bone putty.The patient medical record does not indicate that the bone putty was "tissue".

• Brand Name: OSTEOSURGE 300
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 6121626
• MDR Text Key: 60684949
• Report Number: 6121626
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2016

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 Model Number: SSU-16-07241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR