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

Model Number	46260845
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diagnosis for degenerative scoliosis.Procedure performed was olif.Level at which the implant was performed was l2/3/4/5.It was reported that the cage backed out a bit.Olif was performed on december 19 and posterior fixation was performed on december 26 for the second time at the surgeon's discretion.Surgeon confirmed that the cage between l2/3 that was placed last time was coming out.The reason may be due to the fact that the ag trial did not go in well, so it was changed to a dd trial.There was no patient symptoms or complications as a result of this event.

• Brand Name: ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): ITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer (Section G): ITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16193252
• Report Number: 3006340236-2023-00001
• Device Sequence Number: 6066158
• Product Code: MAX
• UDI-Device Identifier: 00763000128425
• UDI-Public: 00763000128425
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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: 46260845
• Device Catalogue Number: 46260845
• Device Lot Number: UNKNOWN
• 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: 12/26/2022
• Initial Report FDA Received Date: 01/18/2023
• 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: Required Intervention
• Patient Sex: Unknown