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

Catalog Number	MC1005T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an roi-c anchoring plate was discovered broken postoperatively after the patient started having pain.The surgeon has not yet decided if a revision will be performed.
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.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Inspection the product could not be physically evaluated since it remains implanted, however x-ray photos were provided.Review of the x-rays showed that one of the anchoring plates has fractured.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 zimvie¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient, operational, or post-op factors.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that an roi-c anchoring plate was discovered broken postoperatively after the patient started having pain.The surgeon has not yet decided if a revision will be performed.

• Brand Name: ROI-C ANCHORING PLATE
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15523601
• Report Number: 3004788213-2022-00072
• Device Sequence Number: 6056261
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)270101(10)856783
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: 856783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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 Age: 65 YR
• Patient Sex: Female