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

Catalog Number	MC1006T
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two roi-c cages fractured intra-operatively at c6/7 while implanting the superior plates before locking.The plates were misaligned despite using the awl successfully.The level above had a previous plate/screw construct and the procedure was an extension of the previously successful fusion.The procedure was ultimately completed using a competitive product.There was no patient impact; however, there was a 60 minute delay.Upon investigation it was discovered that one of the plates was bent.
Additional Manufacturer Narrative
A review of the dhr was conducted and found no indications of manufacturing issues.An inspection of the part shows that the plate has deformation damage.This event likely cannot be attributed to manufacturing or design related issues.Photos and x-rays were reviewed, they show the anchoring plates were unable to be advanced into the cage.The complaint is confirmed for one roi-c long anchoring plate for the failure of deformation damage.The failure is believed to be attributed to improper use of the awl or hard bone since the provided images show the plate could not advance into the bone.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.This failure may have contributed to the fractured cages referenced in reports 3004788213-2025-00051 and 3004788213-2025-00052.

• Brand Name: ROI-C LONG 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: 24315176
• Report Number: 3004788213-2026-00016
• Device Sequence Number: 11980634
• Product Code: OVE
• UDI-Device Identifier: 03662663016988
• UDI-Public: (01)03662663016988(17)270201(10)864485
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 02/10/2026

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 Catalogue Number: MC1006T
• Device Lot Number: 864485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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