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

Model Number	B20520015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic image review states, the images provided are as below: sagittal ct slice c4/c5, c6/c7 grafts visible.Measure angle c3-c4, c4-c5, c5-c6 and c6-c7.This regulatory report is being submitted due to retrospective review.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 spinal therapy.Pre-op diagnosis of patient was non-specific neural compression (nsnc).It was reported that, this was a revision of a failed surgery.To perform the procedure anterior cervical discectomy and fusion, surgeon had to remove the two previous c-curve implants, carry out a double corpectomy, and implant a mos mesh.It was identified that there was a problem with the c-curve screw during the removal of the implant.Levels implanted during initial surgery was c3-c4 and c6-c7.There was no fragment of broken screws left inside patient body.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information received stating a week after the first intervention, the patient still complained of myelopathy.The first surgery did not solve the patient's pathology.The main cause of the non-fusion was time.Only 1 month has passed between the first and the second intervention.Therefore, the reason for reoperation was mainly a problem with the indication and surgery, not with the implanted material.

• 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: 25412539
• Report Number: 1000432246-2026-00013
• Device Sequence Number: 5939060
• Product Code: OVE
• UDI-Device Identifier: 03613720275688
• UDI-Public: (01)03613720275688(17)300602(10)25F0343
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K210470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: B20520015
• Device Catalogue Number: B20520015
• Device Lot Number: 25F0343
• 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: 04/06/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 07/03/2025
• 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: 50 YR
• Patient Sex: Male