MAUDE Adverse Event Report: LDR MEDICAL ROI-C LORDOTIC IMPLANT H06 12X14MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	MC1442P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
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 during a surgery to extend a construct, while putting the anchoring plate in, an roi-c implant broke where it connects to the inserter.The surgery was completed with another roi-c implant without any patient or procedural complications.
Event or Problem Description
It was reported that during a surgery to extend a construct, while putting the anchoring plate in, an roi-c implant broke where it connects to the inserter.The surgery was completed with another roi-c implant without any patient or procedural complications.
Additional Manufacturer Narrative
Additional information in h6: method, results, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.The device was not returned, however the provided photos show that the device has fractured on the anterior face in multiple spots.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for roi-c lordotic implant 12 x 14 h6 for the failure of fracture.The failure is believed to be attributed to improper attachment to the inserter leading to improper alignment of the cage and the plates because the cage is fractured along the anterior edge of the implant where the plates would be inserted.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.

• Brand Name: ROI-C LORDOTIC IMPLANT H06 12X14MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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: 23707083
• Report Number: 3004788213-2025-00067
• Device Sequence Number: 13424226
• Product Code: OVE
• UDI-Device Identifier: 03662663016537
• UDI-Public: (01)03662663016537(17)260101(10)81424
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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 Expiration Date: 12/31/2025
• Device Catalogue Number: MC1442P
• Device Lot Number: 81424
• 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: 12/03/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic