MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY FORTILINK®-L I BF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	65-L-1845-13-12L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for this complaint as it remains in the patient, therefore no device investigation could be done.Batch information was provided and reviewing manufacturing records yielded no abnormalities.Repeated inquiries to gather more information about this case have not resulted in any additional information beyond what is listed in this report at this time.
Event or Problem Description
Patient developed (b)(6) with wound infection and underwent a wound washout on (b)(6) 2020.Patient was treated with cefazolin and rifampin.At (b)(6) 2020 clinic visit, it was noted that wound was healing well with a very small amount of persistent but improving yellowish drainage at the upper pole of incision.

• Brand Name: PIONEER SURGICAL TECHNOLOGY FORTILINK®-L I BF SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer Contact: cassy baij ; 357 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 12913479
• Report Number: 1833824-2021-00096
• Device Sequence Number: 20105012
• Product Code: MAX
• UDI-Device Identifier: 00846468086534
• UDI-Public: (01)00846468086534(17)230615(10)317550
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/01/2021

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: 06/15/2023
• Device Model Number: 65-L-1845-13-12L
• Device Catalogue Number: 65-L-1845-13-12L
• Device Lot Number: 317550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown