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

Model Number 46261045

Device Problem Use of Device Problem (1670)

Patient Problems Hernia (2240); Stenosis (2263); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Information was received from the healthcare professional via manufacturer representative regarding a patient having olif l4/5 for s pondylolisthesis.It was reported that for the first case of the new patient, the physician commented that it is not about the instruments or implants; the patient was young and had a strong intervertebral disc; the blood vessel branch was slightly upward; the cage was diagonally inserted; and a large cage size was selected, which could have been the cause.Because of the above reasons, the patient developed a hernia from the contralateral side of the foramen, and the symptoms were developed due to a slight nerve root compression.On (b)(6) 2023, decompression was added from the back.Nervous foramen stenosis, additional decompression is stated in the medical record.During the post-operative surgeon confirmed that it was not that it was pressed with a cage and the pressure was applied.There was a slippage, the facet was deformed, and the spinal disc was swollen and compressed.For the intraoperative mep waveforms, the waveforms were small before the operation, but after decompression, the waveforms also increased and improved.

Manufacturer Narrative

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 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.

Manufacturer Narrative

H6.Patient codes has been added.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.

• Brand Name: ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer (Section G): TITAN 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: 16475815
• MDR Text Key: 310588714
• Report Number: 3006340236-2023-00007
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00763000128470
• UDI-Public: 00763000128470
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K212524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46261045
• Device Catalogue Number: 46261045
• Device Lot Number: TM0135306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention