MAUDE Adverse Event Report: ICOTEC AG KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW; Spinal vertebral body replacement device

Model Number	44-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a corpectomy procedure an expandable icotec vbr implant was implanted.Following expansion of the implant the height of the vbr was fixed with the locking screw.The screwdriver intended for locking must be used together with the respective torque limiting handle (1 nm).After checking the implant position the surgeon decided to readjust the position of the vbr.When trying to loosen the set screw, the surgeon noticed that the screwdriver tip had sheared off.The situs was inspected with imaging tools but the fragment was not found.It is therefore assumed that the fragment did not remain in the patient.It was not possible to readjust the position of the vbr.The surgeon decided to leave the implant as it was and to complete the surgery.Due to the result of a follow-up examination (suboptimal placement of the vbr), the surgeon decided to revise the implant.The revision surgery was successfully completed.
Additional Manufacturer Narrative
Production documentation of the screwdriver has been checked, no anomalies were detected when the screwdriver was released to the market.Microstructure and hardness of the device material have been evaluated.No abnormalities were detected.Material properties were within specifications.Torque measurement tests on prototypes made of identical material have been done and have led to the conclusion that the specified torque was achieved.An additional fea (finite element analysis) has been carried out and has shown fractures only well above the specified 1 nm.This confirms the safe use of the instrument during the intended use (use with torque limiting handle).Based on the results of the investigations and the available information, it is not possible to determine the definite root cause for the incident.Based on the information received, over-torsion can not be excluded as the intended handle (with torque limitation) may not have been used in the surgery.

• Brand Name: KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW
• Common Device Name: Spinal vertebral body replacement device
• 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: 17411920
• Report Number: 3006493760-2023-00002
• Device Sequence Number: 6983172
• Product Code: MQP
• UDI-Device Identifier: 07640164847849
• UDI-Public: 07640164847849
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K200235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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: 44-050
• Device Catalogue Number: 44-050
• Device Lot Number: 20/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown