MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 12X14 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1442P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
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.
Event or Problem Description
It was reported that an roi-c cage fractured in the c2/3 disc space intra-operatively while installing the second plate.The cage and plates were removed and replaced with a new cage and plates.The fractured pieces of the cage were recovered.There were no patient impacts.
Event or Problem Description
It was reported that an roi-c cage fractured in the c2/3 disc space intra-operatively while installing the second plate.The cage and plates were removed and replaced with a new cage and plates.The fractured pieces of the cage were recovered.There were no patient impacts.
Additional Manufacturer Narrative
Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the device was not returned for evaluation, an image was provided confirming the fracture.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 IMPLANT 12X14 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 16903809
• Report Number: 3004788213-2023-00041
• Device Sequence Number: 5497104
• Product Code: OVE
• UDI-Device Identifier: 03662663016537
• UDI-Public: (01)03662663016537(17)270101(10)83706H
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/09/2024

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: MC1442P
• Device Lot Number: 83706H
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MC1005T, LOT 846449.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic