MAUDE Adverse Event Report: ICOTEC AG VADER® PEDICLE SYSTEM; VADER® PEDICLE SYSTEM, NUT SCREW, PRODUCT CODE: NKB

Catalog Number	16-57-41000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information regarding a potential cause has been received from the health professional.Icotec attempted to obtain the retrieved devices for investigation.To date, these have not been made available.Analysis of the relevant production records of the devices did not identify any anamolies that could be a cause of the event.Investigation of historical adverse event data determined that icotec has become aware of five similar events with its pedicle system to date.The torque wrench used in initial surgery for final tightening the nut screws could be tested.It is within its specifications and functions as intended.It can therefore be concluded that the torque wrench did not cause the adverse event.Current information is insufficient to permit a valid conclusion of the cause of this event.Based on the information available, no corrective actions are proposed.A follow-up report will be submitted if additional relevant information becomes known.Data relating to manufacturing date is not on the label as udi-pi.
Event or Problem Description
Mfr report #: 3006493760-2026-00001.A patient was implanted with an icotec pedicle screw system ((b)(6) 2025).Post-surgery three nut screws (set screws) loosened (exact date were not reported).X-ray imaging shows that the pedicle system was used together with two iliac screws (from an unknown manufacturer).A revision surgery was performed and implants were replaced ((b)(6) 2026).

• Brand Name: VADER® PEDICLE SYSTEM
• Common Device Name: VADER® PEDICLE SYSTEM, NUT SCREW, PRODUCT CODE: NKB
• Manufacturer (Section D): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• MDR Report Key: 25344876
• Report Number: 3012602431-2026-00047
• Device Sequence Number: 12084774
• Product Code: NKB
• UDI-Device Identifier: 07640140431994
• UDI-Public: 07640140431994
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2026
• Report Date (Section F): 05/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 16-57-41000
• Device Lot Number: 24/01, 24/05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/31/2026