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

Model Number	16-57-41000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report #: 3006493760-2026-00003 a patient noticed increasing pain which led to a follow-up imaging (date not reported) where it was noticed that nut screws loosened.A revision surgery was performed ((b)(6) 2026).During the revision it was detected that two pedicle screws were broken.The surgeon decided to replace the pedicle system.Earlier ((b)(6) 2023), the patient had implanted an icotec pedicle system with a revision on (b)(6) 2024 (mdr no.(b)(4) where the surgeon decided to implant a 5.5 mm diameter pedicle rod from a third party manufacturer (off-label).During this revision the rod was secured in the pedicle screws using new icotec nut screws.
Additional Manufacturer Narrative
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 nut screws and pedicle screws did not identify any anamolies that could be a cause of the event.The torque wrenches used in the surgery for final tightening the nut screws were tested at icotec.The instruments functioned as intended.It can therefore be concluded that the torque wrench was not the root cause of the adverse event.The use of icotec pedicle screws and icotec nut screws together with a 5.5 mm diameter pedicle rod from a third-party manufacturer (off-label) has not been tested and approved by icotec.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 submitte.

• 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
• MDR Report Key: 25345301
• Report Number: 3012602431-2026-00052
• Device Sequence Number: 5105581
• Product Code: NKB
• UDI-Device Identifier: 07640140431994
• UDI-Public: 07640140431994
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Model Number: 16-57-41000
• Device Catalogue Number: 16-57-41000
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2026
• 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