MAUDE Adverse Event Report: ICOTEC AG VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 6.5 X 50 MM

Model Number	16-6022-56550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the relevant production records of the pedicle screws did not identify any anabolies that could be a cause of the event.The evaluation of the returned pedicle screw did not lead to a clear conclusion of the root cause.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 in switzerland was treated on (b)(6) 2024 with 4 pedicle screws t9 and t11 with a tumor beeing present at t10.The patient noticed increasing pain (date between on (b)(6) 2025 and on (b)(6) 2026).At the hospital, it was diagnosed that t10 had collapsed.During imaging it was additionally noticed that the screw t11 left was loose.A revision surgery was planned and conducted on (b)(6) 2026 where it was noticed that the screw t11 right has broken.During the revision surgery the surgeon replaced the screw in t11 left and treated an additional level t12 with a screw left and right.The surgeon decided to leave the broken off shaft of the screw in t11 right in the patient.

• Brand Name: VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 6.5 X 50 MM
• Common Device Name: VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 6.5 X 50 MM
• Manufacturer (Section D): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer (Section G): ICOTEC AG; industriestrasse 15; altstaetten, sg 9450 ; SZ 9450
• Manufacturer Contact: joerg schneider ; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• MDR Report Key: 25356813
• Report Number: 3006493760-2026-00005
• Device Sequence Number: 10654289
• Product Code: NKB
• UDI-Device Identifier: 07640164844756
• UDI-Public: 07640164844756
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K232628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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
• Device Model Number: 16-6022-56550
• Device Catalogue Number: 16-6022-56550
• Device Lot Number: 23/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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