MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	4675020
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with spacer and screw having l4/5,5/s oblique lateral interbody fusion (olif) therapy for lumbar spinal stenosis.It was reported that l4/5 clyesdale ptc spacer was installed without any issues and l5/s was approached through a separate incision.The procedure progressed smoothly until the retractor was placed, and the cage was installed with 12 degrees.A pilot hole was created, and the bone screw was inserted.However, the screw did not go in smoothly, and the process of creating a pilot hole and inserting the screw was repeated several times.The direction of the screw did not align with the cage's screw hole, so the screw was reinserted using the inserter as a guide, and the screw was eventually installed successfully.Upon removing the screwdriver, bleeding from the left common iliac artery was observed.Hemostasis was achieved by applying a tachosil and compressing for about 15 minutes.Finally, surgiflo was used to ensure hemostasis, the area was irrigated, and it was confirmed that there was no furtherbleeding before closing the wound.Because the issue was noticed early, the intraoperative blood loss was minimal.There was a delay of less than 60 minutes in the overall procedure.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B2: outcome attributed to adverse event- tachosil and surgiflo was used to ensure hemostasis.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.
Additional Manufacturer Narrative
Annex f code corrected.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.

• Brand Name: ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 19717147
• Report Number: 1030489-2024-00807
• Device Sequence Number: 18179616
• Product Code: KWQ
• UDI-Device Identifier: 00763000508791
• UDI-Public: 00763000508791
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 4675020
• Device Catalogue Number: 4675020
• Device Lot Number: RM21J012
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/24/2024
• Date Device Manufactured: 03/10/2022
• 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; Required Intervention
• Patient Sex: Unknown