MAUDE Adverse Event Report: ICOTEC AG VADER PEDICLE SYSTEM, ROD

Model Number	16-60-2MC30-3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was treated with the icotec pedicle system (t11-l5) together with an anterior fibular graft strut in a surgery ((b)(6) 2023).Post-op, it was detected that the two pedicle rods have broken and the fibular graft strut was tilted.No neurological compromise was noted.A revision surgery was performed on the (b)(6) 2023.
Additional Manufacturer Narrative
Analysis of the relevant production records did not identify any anomalies that could be a cause of the event.Retrieved implants not yet available for investigation.

• Brand Name: VADER PEDICLE SYSTEM, ROD
• Common Device Name: VADER PEDICLE SYSTEM
• 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: 18534674
• Report Number: 3006493760-2024-00002
• Device Sequence Number: 7772991
• Product Code: NKB
• UDI-Device Identifier: 07640172551738
• UDI-Public: 07640172551738
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K222789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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: 16-60-2MC30-3
• Device Catalogue Number: 16-60-2MC30-3
• Device Lot Number: 22/01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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