MAUDE Adverse Event Report: TITAN SPINE, A DIVISION OF MEDTRONIC ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	46260855
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: patient was bleeding and admitted in intensive care unit (icu).E: first name and last name of initial reporter is unknown.G2: country of origin is japan.H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via manufacturer representative regarding patient having l4/5, l5/s olif due to isolation.Level implanted was l4/5, l5/s.It was reported that the common iliac vein was damaged and a large amount of hemorrhaging occurred which may lead to death or disability.Bleeding was observed gradually after the l5/s implant was inserted and attempted to stop the bleeding with the hemostatic agent floseal and surge flow, but hemostasis could not be achieved.When the wound retractor was removed, a large amount of hemorrhaging was observed and the bleeding was suppressed with gauze, but hemostasis could not be achieved, so a surgeon from cardiovascular surgery was contacted to come.The position was changed from lateral to supine and then switched to the cardiovascular surgeon, the bleeding site is specified and then sutured to stop the bleeding.Blood pressure dropped to 50 midway, but recovered.According to the cardiovascular surgeon, vein was pushed slightly, but it would probably be okay.The patient might experience swelling after the surgery, but it will return to normal.According to the surgeon, the bleeding gradually occurred when the device was inserted with a hammer during the trial.A little more came out when the real thing or when the screw was inserted.It might have ruptured the blood vessel when the space between the vertebrae was widened during the trial.Furthermore, the surgeon around the patient was not able to detach properly, and might have been caught with the retractor.The cardiovascular surgeon said that the back side of the lateral wall of the common iliac vein had ruptured.There was a delay of greater than 60 minutes occurred and no further complications or symptoms reported.Additional information was received via manufacturer representative that the cause of the event is unknown, but however it is considered as user error.It was observed that the bleeding started gradually after the devices were inserted.There may be a possibility of the blood vessel torn when the devices were inserted, but there are no complaints about the implant.The blade may have caught a blood vessel.There is no plan to remove the products.The patient seems to be in a state where he cannot make predictions while still in the icu.

• Brand Name: ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee WI 53092
• Manufacturer (Section G): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee WI 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22858103
• Report Number: 3011577940-2025-00005
• Device Sequence Number: 21172025
• Product Code: MAX
• UDI-Device Identifier: 00763000128449
• UDI-Public: (01)00763000128449(17)311110(10)TM0143587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46260855
• Device Catalogue Number: 46260855
• Device Lot Number: TM0143587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 11/10/2023
• 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
• Patient Ethnicity: Non Hispanic