MAUDE Adverse Event Report: LDR MEDICAL ROI-C LORDOTIC COATED IMPLANT 14X 17 H8; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	CMC1434P
Medical Device Problem Code	Fracture (1260)
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.This is report two of two for this event.
Additional Manufacturer Narrative
D10: 2x roi-c long anchoring plates (mc1006t), 1x unknown roi-c inserter.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3004788213-2025-00051.
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.This is report two of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.H6: additional method code: 4109 corrections in 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: this event could possibly be attributed to incorrect use of the awl, resulting in misalignment of the plates and excessive forces being applied to the cage.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.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 14X 17 H8
• 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: 22964512
• Report Number: 3004788213-2025-00052
• Device Sequence Number: 9151466
• Product Code: OVE
• UDI-Device Identifier: 03662663023504
• UDI-Public: (01)03662663023504(17)271001(10)C94720
• 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,Followup
• 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: CMC1434P
• Device Lot Number: C94720
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2025
• 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: 09/04/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic