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

Model Number 16-60-2MC30-3

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 12/23/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 333125606
• Report Number: 3006493760-2024-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07640172551738
• UDI-Public: 07640172551738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention