MAUDE Adverse Event Report: LDR MEDICAL IMPLANT ROI-C 12X14 H7; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	MC1343P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
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 the removal area of the roi-c peek cage fractured during cage implantation.When the cage was inserted into the disc space before inserting the plate, the surgeon found the fractured piece in the patient.The cage was removed and replaced.There was no patient harm and only a 10 minute delay.
Additional Manufacturer Narrative
H6: additional method code: 4109.Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the cage has fractured.Root cause: according to dmr-14-sm-20-a, rev.(roi-c mechanical test report), this kind of failure can be a result of excessive dynamic torsional loading.This event could be attributed to excessive torsional forces applied to the implant during insertion and/or adjustment of the position in the disc space.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 medical¿s control.Device usage: 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.
Event or Problem Description
It was reported that the removal area of the roi-c peek cage fractured during cage implantation.When the cage was inserted into the disc space before inserting the plate, the surgeon found the fractured piece in the patient.The cage was removed and replaced.There was no patient harm and only a 10 minute delay.

• Brand Name: IMPLANT ROI-C 12X14 H7
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, 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: 22536070
• Report Number: 3004788213-2025-00044
• Device Sequence Number: 8028141
• Product Code: ODP
• UDI-Device Identifier: 03662663016292
• UDI-Public: (01)03662663016292(17)270401(10)C90620
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091088
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: Health Professional
• Device Catalogue Number: MC1343P
• Device Lot Number: C90620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• 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
• Patient Ethnicity: Non Hispanic