MAUDE Adverse Event Report: ICOTEC AG VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 7.5 × 45 MM

Model Number	16-6022-57545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was treated with the icotec pedicle system in a surgery ((b)(6) 2023).The patient noticed increasing pain.On (b)(6) 2025 it was detected that one pedicle screw has broken.A revision surgery (date not reported) was performed and the implants have been replaced.
Additional Manufacturer Narrative
Data relating to manufacturing date is not on the label as udi-pi.No information regarding a potential cause has been received from the health professional.Analysis of the relevant production records of the pedicle screw did not identify any anomalies that could be a cause of the event.The evaluation of the returned pedicle screw is still ongoing.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.

• Brand Name: VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 7.5 × 45 MM
• Common Device Name: VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 7.5 × 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: 21958276
• Report Number: 3006493760-2025-00002
• Device Sequence Number: 17948922
• Product Code: NKB
• UDI-Device Identifier: 07640164844817
• UDI-Public: 07640164844817
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K232628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 16-6022-57545
• Device Lot Number: 23/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2023
• 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