MAUDE Adverse Event Report: ICOTEC AG VADER® PEDICLE SYSTEM; VADER® PEDICLE SYSTEM, ROD, CARBON/PEEK, CURVED, Ø 6.0 R450 <-> 200 MM

Catalog Number	16-60-24520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information regarding a potential cause has been received from the health professional.The broken rods cannot be investigated because they were discarded at the hospital.Analysis of the relevant production records did not identify any anomalies that could be a cause of the event.Investigation of historical adverse event data determined that icotec has become aware of two similar events with these devices to date.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
A patient was implanted with an icotec pedicle screw system ((b)(6) 2025).Post-surgery two pedicle rods break (exact date not reported).X-ray imaging indicates that anterior column support was not present or only very marginal.A revision surgery was performed and implants were replaced ((b)(6) 2026).Additional level of screws and a corpectomy cage were placed.

• Brand Name: VADER® PEDICLE SYSTEM
• Common Device Name: VADER® PEDICLE SYSTEM, ROD, CARBON/PEEK, CURVED, Ø 6.0 R450 <-> 200 MM
• 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: 24532091
• Report Number: 3006493760-2026-00002
• Device Sequence Number: 8972044
• Product Code: NKB
• UDI-Device Identifier: 07640172551905
• UDI-Public: 07640172551905
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K242900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 16-60-24520
• Device Lot Number: 22/01
• 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
• Date Device Manufactured: 12/21/2022
• 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