MAUDE Adverse Event Report: ICOTEC AG KONG-TL VBR E, EXPANDABLE BODY, STANDALONE, XS, Ø 19 MM X 22 - 29 MM

Model Number	12-91-1922-9
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was treated with the icotec pedicle system and an icotec expandable vbr in a surgery (b)(6) 2024).The patient noticed increasing pain.On (b)(6) 2025, it was detected that the vbr has collapsed and two pedicle screws have broken.A revision surgery was performed.
Additional Manufacturer Narrative
Data relating to manufacturing date is not on the label as udi-pi.Analysis of the relevant production records of the expandable vbr and the pedicle screws did not identify any anomalies that could be a cause of the event.Investigation of historical adverse event data determined that icotec has not become aware of any similar events with this devices to date.The retrieved implants have been investigated in our facilities with the following findings: it is assumed that the kong-tl vbr was gradually collapsing over time because the locking screw was not properly placed and therefore was not able to prevent axial movement of the internal mechanism.The gradual collapse of the anterior support might have led to an overload of the posterior fixation with a subsequent fracture of the two pedicle screws.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: KONG-TL VBR E, EXPANDABLE BODY, STANDALONE, XS, Ø 19 MM X 22 - 29 MM
• Common Device Name: KONG-TL VBR E, EXPANDABLE BODY, STANDALONE, XS, Ø 19 MM X 22 - 29 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: 21858459
• Report Number: 3006493760-2025-00001
• Device Sequence Number: 20004720
• Product Code: MQP
• UDI-Device Identifier: 07640164847412
• UDI-Public: 07640164847412
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K232790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/17/2025

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: 12-91-1922-9
• Device Catalogue Number: 12-91-1922-9
• Device Lot Number: 24/01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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