MAUDE Adverse Event Report: LDR MEDICAL ROI-A ANCHORING PLATE L; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	IR2007T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Neuralgia (4413)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient had a return of pain in the lower spine and radiating down the legs three months post-operatively.Additional pain medication did not improve the patient's symptoms.A follow-up radiological study showed findings consistent with pseudoarthrosis, segmental vertebral instability, and cage displacement at the surgical site (l4/l5 segment).Additionally, an anchoring plate was fractured.A revision surgery was performed to add a two-level posterior mis screw construct to l4/l5.The implant will not be removed, and the patient is now doing well and without pain.This is report one of two for this event.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.The device was not returned, however x-ray images were provided which show that an anchoring plate has fractured.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for roi-a anchoring plate for the failure of fracture post-op requiring revision surgery.A definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3004788213-2025-00064.
Event or Problem Description
It was reported that a patient had a return of pain in the lower spine and radiating down the legs three months post-operatively.Additional pain medication did not improve the patient's symptoms.A follow-up radiological study showed findings consistent with pseudoarthrosis, segmental vertebral instability, and cage displacement at the surgical site (l4/l5 segment).Additionally, an anchoring plate was fractured.A revision surgery was performed to add a two-level posterior mis screw construct to l4/l5.The implant will not be removed, and the patient is now doing well and without pain.This is report one of two for this event.

• Brand Name: ROI-A ANCHORING PLATE L
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23438057
• Report Number: 3004788213-2025-00063
• Device Sequence Number: 4783228
• Product Code: MAX
• UDI-Device Identifier: 03662663010979
• UDI-Public: (01)03662663010979(17)260301(10)288910/1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153495
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: IR2007T
• Device Lot Number: 288910/1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic