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

Model Number	46221045
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a l2/3 stand-alone olif with pivox plate in a patient who had previous surgery from l3-pelvis with screws and interbodies.Levels implanted were l2/3.It was reported that the anteralign ts cage spit out to the side of l2/3 where the implant was placed. revision surgery included removal of anteralign and pivox plate that was attached.There were no patient symptoms reported.There were no further complications reported regarding the event.The spacer was replaced by a clydesdale ptc implant and extended the patient's psf levels up to l2.
Additional Manufacturer Narrative
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
Radiographic image review comments concluded that ap xray at interbody graft spinal level appears extruded anteriorly, and plate is depleted off vertebral body spinal level.Lateral view of first x ray, posterior screw fixation, l3 - iliac.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¿
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20437768
• Report Number: 3006340236-2024-00012
• Device Sequence Number: 8090932
• Product Code: MAX
• UDI-Device Identifier: 00763000128777
• UDI-Public: 00763000128777
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 46221045
• Device Catalogue Number: 46221045
• Device Lot Number: TM0138811
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/19/2024
• Date Device Manufactured: 06/06/2022
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown