MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA C-CURVE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F

Model Number	B20502153
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: the country of the event is ireland.Radiographic image review determined that phone capture of fluro screen of cervical discectomy and fusion was provided.Interbody fusion device does not appear correctly placed in disc space.Unable to count levels on angle provided.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having c7/t1 acdf for an indication of cervical stenosis at level c7/t1 under existing fusion.It was reported that while trying to remove the screw and reposition the cage, the screw was turning but not coming out.As the screw was not removed, a venture plate was implanted to prevent the cage from migrating.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: C-CURVE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21523284
• Report Number: 1000432246-2025-00013
• Device Sequence Number: 9584785
• Product Code: OVE
• UDI-Device Identifier: 03613720275084
• UDI-Public: 03613720275084
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K210470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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 Model Number: B20502153
• Device Catalogue Number: B20502153
• Device Lot Number: 23D0309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 04/26/2023
• 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 Age: 73 YR
• Patient Sex: Male