MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 14X 17 H8; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	CMC1434P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an roi-c cage was found to have cracked when the inserter was taken off after the plates were implanted intra-operatively.The cage and pates were removed and replaced.There was a delay of 20 minutes, but there were no 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 an roi-c cage was found to have cracked when the inserter was taken off after the plates were implanted intraoperatively.The cage and pates were removed and replaced.There was a delay of 20 minutes, but there were no patient impacts.
Additional Manufacturer Narrative
Corrections in d4: udi number, g1, and h3.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Inspection the device was not returned for evaluation and images were not provided.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.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.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 14X 17 H8
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 16526187
• Report Number: 3004788213-2023-00022
• Device Sequence Number: 11418071
• Product Code: OVE
• UDI-Device Identifier: 03662663023504
• UDI-Public: (01)03662663023504(17)240701(10)73184
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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 Expiration Date: 06/30/2024
• Device Catalogue Number: CMC1434P
• Device Lot Number: 73184
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• 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 Age: 40 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic