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	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that the first screw - thread inside screw (in slot where screwdriver inserts) thread came off in little metal pieces and was unable to advance screw any further and also unable to remove screw (screw and cage as it was now fixed inside).The second screw on second level, the screw head broke off with the threaded shaft in patient and head part broke off during implantation.Surgeon was able to remove head part and was unable to advance screw any further and also unable to remove screw (screw and cage as it was now fixed inside).Cages in place but not as full seated as surgeon would prefer.There was no confirmed plan for a revision surgery to explant the broken screws.The procedure performed was a anterior cervical discectomy and fusion.The implants were placed in levels c5¿c6 and c6-c7.There were no patient symptoms reported.No further complications reported regarding the event.
Additional Manufacturer Narrative
Radiographic image review states, the left picture shows explanted broken screw fragments.Right ¿ level anterior cervical discectomy and fusion.Top level bottom screw poor angle.Bottom level top screw poor angle.H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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.

• 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: 25424384
• Report Number: 1000432246-2026-00017
• Device Sequence Number: 9929326
• Product Code: OVE
• UDI-Device Identifier: 03613720275688
• UDI-Public: (01)03613720275688(17)300219(10)25C0256
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K210470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/08/2026

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: 25C0256
• 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: 06/08/2026
• Date Device Manufactured: 03/20/2025
• 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: Unknown