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

Model Number	B20520017
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/01/2025
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.Pre-op diagnosis of patient was discopathy.It was reported that, the head of the screw broke at the last tightening.The levels implanted were c4-c5.Fragment of broken screw was left inside patient body.Procedure performed was fusion and fixation.There was no plan to perform revision surgery.There were no patient symptoms reported.No further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis of part#: b20520017; lot#: 24f0224 the product being returned is the head of the screw.The hypothesis is that the surgeon may have not performed the preparation step for the insertion (using the square awl) or maybe have not used the holder during the screw insertion leading to a misalignment of force and breakage of the screw.Without additional information of the surgical steps, no further conclusion can be reached on this case.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 TI
• 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: 23276963
• Report Number: 1000432246-2025-00025
• Device Sequence Number: 5507410
• Product Code: OVE
• UDI-Device Identifier: 03613720275671
• UDI-Public: (01)03613720275671(17)290526(10)24F0224
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/13/2025

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: B20520017
• Device Catalogue Number: B20520017
• Device Lot Number: 24F0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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 Sex: Unknown