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

Model Number	4675030
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient who had l5-s1 alif due to ddd.It was reported that ls screw backed out of cage after being final tightened.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B3: event date is not known.H6 : the device was 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
Radiographic image review: - magnified view of the l5-s1 interbody graft shows that the l5 set screw is slightly backed out.- lateral view: the l5 screw appears correctly inserted.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: 19929209
• Report Number: 1030489-2024-00936
• Device Sequence Number: 14134515
• Product Code: KWQ
• UDI-Device Identifier: 00763000508807
• UDI-Public: 00763000508807
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 4675030
• Device Catalogue Number: 4675030
• Device Lot Number: RM22L075
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 03/14/2023
• 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
• Patient Sex: Male