MAUDE Adverse Event Report: LDR MEDICAL ANCHORING PLATE M; AVENUE L LATERAL LUMBAR CAGE SYSTEM

Catalog Number	IR6002T
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an avenue l plate seems to have backed out a little from the cage post-operatively.There is no revision surgery planned as there was no impact to the patient.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Additional Manufacturer Narrative
H6 additional investigation type code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Inspection product will not be returning as it remains implanted, however x-rays show that the plate backed out of the cage.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that an avenue l plate seems to have backed out a little from the cage post-operatively.There is no revision surgery planned as there was no impact to the patient.
Additional Manufacturer Narrative
H6 additional investigation type code: 4109.Additional information in h6: investigation type, findings, and conclusions.Inspection: product will not be returning as it remains implanted, however post-operation x-rays show that the inferior plate has backed out of the cage.Intra-operation x-rays also show that the ends of the two anchoring plates are not flush with each other, indicating the inferior plate is not fully seated and locked.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.Potential root cause: this event could possibly be attributed to insufficient advancement of the plate into the cage during the operation, preventing the plate from locking and leading to post-operation migration.Device usage:: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that an avenue l plate seems to have backed out a little from the cage post-operatively.There is no revision surgery planned as there was no impact to the patient.

• Brand Name: ANCHORING PLATE M
• Common Device Name: AVENUE L LATERAL LUMBAR CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18499241
• Report Number: 3004788213-2024-00002
• Device Sequence Number: 7901142
• Product Code: MAX
• UDI-Device Identifier: 03662663008327
• UDI-Public: (01)03662663008327(17)260601(10)842302
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153495
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2025

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: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: IR6002T
• Device Lot Number: 842302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 06/23/2024; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAGE, IR6330P, LOT 84115
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic