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

Catalog Number	16-57-41000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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).
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.

• Brand Name: VADER® PEDICLE SYSTEM
• Common Device Name: VADER® PEDICLE SYSTEM, NUT SCREW
• Manufacturer (Section D): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer (Section G): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer Contact: joerg schneider ; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• MDR Report Key: 24532096
• Report Number: 3006493760-2026-00001
• Device Sequence Number: 9070808
• Product Code: NKB
• UDI-Device Identifier: 07640140431994
• UDI-Public: 07640140431994
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K242900
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown