MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGIES FORTILINK-L TETRAFUSE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	65-L-2250-13-6L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgalign director of (b)(6) informed us of a complaint involving a study patient, "date of event: 3-23-2022.Subject presents today with worsening low back pain and extends into her buttocks.The pain improves whenever the patient bends in a forward position.The l4-5 posterior instrumentation demonstrates to be stable.Subject is getting an updated mri to further evaluate the pathology.Once the exam has been completed she will follow up with her doctor to review the results and decide on any further treatment.Subject stated the pain began about a year ago, but could not give a particular date.Date of surgery: 11-7-2019.".
Additional Manufacturer Narrative
Device not inspected due to remaining in the patient.No batch information was provided, so the manufacturing records could not be investigated.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.
Additional Manufacturer Narrative
Device not inspected due to remaining in the patient.A dhr review has been conducted and confirmed that the device met specification prior to shipping.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
Surgalign director of quality (b)(6) informed us of a complaint involving a study patient, "date of event: 3-23-2022.Subject presents today with worsening low back pain and extends into her buttocks.The pain improves whenever the patient bends in a forward position.The l4-5 posterior instrumentation demonstrates to be stable.Subject is getting an updated mri to further evaluate the pathology.Once the exam has been completed she will follow up with her doctor to review the results and decide on any further treatment.Subject stated the pain began about a year ago, but could not give a particular date.Date of surgery: (b)(6) 2019.".

• Brand Name: PIONEER SURGICAL TECHNOLOGIES FORTILINK-L TETRAFUSE
• 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: 14429037
• Report Number: 1833824-2022-00050
• Device Sequence Number: 6530977
• Product Code: MAX
• UDI-Device Identifier: 00846468085957
• UDI-Public: (01)00846468085957(17)231118(10)330854
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192718
• 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,Followup
• Report Date (Section B): 05/17/2022

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: 11/13/2023
• Device Model Number: 65-L-2250-13-6L
• Device Catalogue Number: 65-L-2250-13-6L
• Device Lot Number: 330854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown