MAUDE Adverse Event Report: ICOTEC AG VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 5.5 X 45 MM

Model Number	16-6022-55545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Data relating to manufacturing date is not on the label as udi-pi.Analysis of the relevant production records of the pedicle screw did not identify any anamolies that could be a cause of the event.The hospital was requested to return the retrieved pedicle screws for investigation.The implants will not be returned as the patient decided to keep the implants 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.
Event or Problem Description
A patient in switzerland was treated with an icotec pedicle screw system (8 pedicle screws).The patient noticed increasing pain.Imaging revealed a possible infection in the location of the implants and loosened pedicle screws.A revision surgery was required.During the revision surgery (b)(6) 2025) all screws were removed whereby one screw broke.

• Brand Name: VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 5.5 X 45 MM
• Common Device Name: VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 5.5 X 45 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: 23028787
• Report Number: 3006493760-2025-00005
• Device Sequence Number: 18445747
• Product Code: NKB
• UDI-Device Identifier: 07640164844671
• UDI-Public: 07640164844671
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 16-6022-55545
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown