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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an roi-c superior plate at c5/6 was found to have fractured six months post-operatively via x-rays.The patient was inactive and the cage did not show signs of sinking (movement) post-operatively.The awl was used prior to installing the plates when they were installed in the patient.There are no health impacts and no plans for a revision surgery.
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 method code: (b)(4).Corrections in d4: udi number.Additional information in d4 expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the device remains implanted, so it was not returned and an evaluation is unable to be performed.X-rays were provided, which show that one of the anchoring plates is fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: per dhr review, the part was likely conforming when it 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 an roi-c superior plate at c5/6 was found to have fractured six months post-operatively via x-rays.The patient was inactive and the cage did not show signs of sinking (movement) post-operatively.The awl was used prior to installing the plates when they were installed in the patient.There are no health impacts and no plans for a revision surgery.

• 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: 16480984
• Report Number: 3004788213-2023-00019
• Device Sequence Number: 19632914
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)270201(10)866439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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: Other
• Device Catalogue Number: MC1005T
• Device Lot Number: 866439
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic