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

Model Number	65-C-1214-6-6L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Death
Additional Manufacturer Narrative
No product was returned for this complaint.Therefore, no device investigation could be done other than a review of the manufacturing records related to the part.According to the dhr, the product was manufactured to specifications.Repeated inquires to gather more information about this case have not resulted in any additional information beyond what is listed in this report.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 or Problem Description
On (b)(6) 2021, it was reported to pioneer surgical technology that a death had occurred for a patient that was enrolled in a post market retrospective clinical study.Based on the limited information received by pioneer surgical technology, the patient reportedly died of a stroke on (b)(6) 2020.Initial surgery for this patient was on (b)(6) 2019.There was no reported evidence that this death was caused by the surgery or pioneer surgical technology's implant.

• Brand Name: PIONEER SURGICAL TECHNOLOGY FORTILINK C
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• MDR Report Key: 12488532
• Report Number: 1833824-2021-00076
• Device Sequence Number: 4264870
• Product Code: MAX
• UDI-Device Identifier: 00846468080341
• UDI-Public: (01)00846468080341(17)231031(10)329592
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 65-C-1214-6-6L
• Device Catalogue Number: SAME
• Device Lot Number: 329592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death