MAUDE Adverse Event Report: LDR MEDICAL ROI-C SHORT ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1005T
Medical Device Problem Codes	Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed 1-2 years post-operatively to address metallosis and non-fusion of an roi-c patient.The patient was experiencing pain prior to the revision.Using spect-ct, the surgeon determined that the cage was loose and that there was a visible amount of metallosis.This is report one of two for this event.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos or x-rays were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to inadequate vertebral body end plate preparation.This is assuming that the anchoring plates were correctly installed, and without knowing the patient¿s smoker status or having a diabetic condition.If all residual disc material was not removed from the disc space, especially around the area of the hole in the spacer in which the bone replacement matrix is added, then bone will be unable to grow from one endplate through the center of the spacer and to the opposite endplate.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.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.Reference report 3004788213-2024-00083.
Event or Problem Description
It was reported that a revision surgery was performed 1-2 years post-operatively to address metallosis and non-fusion of an roi-c patient.The patient was experiencing pain prior to the revision.Using spect-ct, the surgeon determined that the cage was loose and that there was a visible amount of metallosis.This is report one of two for this event.

• Brand Name: ROI-C SHORT ANCHORING PLATE
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• 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: 20578717
• Report Number: 3004788213-2024-00082
• Device Sequence Number: 8003241
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MC1005T
• 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: 10/31/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic