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

Model Number	46841220
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a manufacturer representative regarding an event which occurred during l 3/4 olif procedure in a patient diagnosed with l3/4/5 lcs.It was reported that the operation was performed in the first period, in which the olif 2 intervertebral and posterior fusions were divided into two periods.The first term was completed by inserting a cage, plate & screw between the 2 intervertebral of l3/4/5.The second period of posterior fixation was performed with non-medtronic hardware.Between the first and second period, about one-third of the l3/4 cage came off in one week.The cage that had come loose was to be driven in again, so only the screws in the plate were removed, the plate and cage were driven in as they were, fitted between the vertebrae, and finished after compression was applied at the time of posterior fixation.There was a delay of less than 60 mins.There was no patient symptom reported.There were no further complications reported regarding the event.

• 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: 20208233
• Report Number: 1030489-2024-01123
• Device Sequence Number: 20537078
• Product Code: KWQ
• UDI-Device Identifier: 00763000510787
• UDI-Public: 00763000510787
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46841220
• Device Catalogue Number: 46841220
• Device Lot Number: RM21K047
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/12/2024
• Date Device Manufactured: 07/18/2022
• 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
• Patient Sex: Unknown