MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY FORTILINK IBF SYSTEM; INTERBODY FUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2020

Event Type  Death  

Manufacturer Narrative

The device remains implanted in patient.The device was not returned to rti surgical for evaluation.A dhr review was not conducted since the device part and lot information was not available.Based on the information gathered from this occurrence, there is no evidence that pioneer surgical's device nor the procedure were the cause of the patient's death.

Event Description

It was reported to pioneer surgical that during a retrospective clinical study the following information was discovered: a fortilink device was implanted into a patient at an unknown date.On (b)(6) 2019 the patient was doing well and spine health was improving.On 03/02/2020, the study site received information from the patient's family that the patient had died on (b)(6) 2020.Further information from the patient's family was that the patient's death was not related to the device and implant procedure.The patient's family reported that the death was related to the patient's underlying pulmonary and cardiac health and that the patient had a history of pulmonary issues.

• Brand Name: FORTILINK IBF SYSTEM
• Type of Device: INTERBODY FUSION DEVICE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 12321501
• MDR Text Key: 266564135
• Report Number: 1833824-2021-00055
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death