MAUDE Adverse Event Report: LDR MEDICAL ROI-C SHORT ANCHORING PLATE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	MC1005T
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: part cmc1342p, lot c103081 (roi-c coated implant 12x14x6) 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 after cage insertion, a pilot hole was drilled to full depth with an awl, but the anchoring plate was not able to go in all the way.The plate was discarded, the depth was adjusted, and the procedure was completed with another plate without resulting in any patient harm, and only a 10 minute procedural delay.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: this event could be attributed to the pilot hole not being drilled to the correct depth initially, as reported.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 after cage insertion, a pilot hole was drilled to full depth with an awl, but the anchoring plate was not able to go in all the way.The plate was discarded, the depth was adjusted, and the procedure was completed with another plate without resulting in any patient harm, and only a 10 minute procedural delay.

• Brand Name: ROI-C SHORT ANCHORING PLATE
• 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: 22320288
• Report Number: 3004788213-2025-00036
• Device Sequence Number: 8924432
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)290701(10)291411/16
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 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: MC1005T
• Device Lot Number: 291411/16
• 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
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2024
• 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: SEE H10
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic