MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 14X14 H5; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1311P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an roi-c cage broke during the introduction of the anchoring plate.The plate would not deploy once the cage fractured.The cage and plate were replaced and the procedure was completed.There were no reported patient impacts.
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.
Event or Problem Description
It was reported that an roi-c cage broke during the introduction of the anchoring plate.The plate would not deploy once the cage fractured.The cage and plate were replaced and the procedure was completed.There were no reported patient impacts.
Additional Manufacturer Narrative
Corrections in d4: udi number.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation the product was not returned and no photos were provided, so an evaluation is unable to be performed.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 excess force applied during insertion or incorrect anchor plate trajectory.Device usage: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: ROI-C IMPLANT 14X14 H5
• 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: 15565067
• Report Number: 3004788213-2022-00075
• Device Sequence Number: 6157953
• Product Code: OVE
• UDI-Device Identifier: 03662663016063
• UDI-Public: (01)03662663016063(17)270301(10)C90607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: MC1311P
• Device Lot Number: C90607
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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 Sex: Unknown