MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 14X15,5 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	CMC1422P
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
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.Reference report 3004788213-2022-00034.
Event or Problem Description
It was reported that a broken roi-c anchoring plate was found in an x-ray taken approximately 6 months postoperatively.Also, the surgeon believes the cage may have subsided.The cage was placed at level c5/6 and the plate broke at c6.At this time, there are no reported plans for revision surgery, but the patient is feeling some numbness.This is report one of two for this event.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product has not been returned, but an x-ray was provided showing the post-op plate fracture and cage subsidence.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient, operational or post-op factors.Dhr review: per dhr review, the parts were likely conforming when they left zimvie 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 a broken roi-c anchoring plate was found in an x-ray taken approximately 6 months postoperatively.Also, the surgeon believes the cage may have subsided.The cage was placed at level c5/6 and the plate broke at c6.At this time, there are no reported plans for revision surgery, but the patient is feeling some numbness.This is report one of two for this event.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 14X15,5 H6
• 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: 14337308
• Report Number: 3004788213-2022-00033
• Device Sequence Number: 5237003
• Product Code: OVE
• UDI-Device Identifier: 03662663023429
• UDI-Public: (01)03662663023429(17)260901(10)87374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Expiration Date: 09/01/2026
• Device Catalogue Number: CMC1422P
• Device Lot Number: 87374
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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: Male
• Patient Weight: 65 KG