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	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user has confirmed that the surgery was performed in accordance with ifu.Analysis of the relevant production records of the screwdriver did not identify any anomalies that could be a cause of the event.The broken screwdriver was returned to icotec and the investigation of the breakage has been started.
Event or Problem Description
When tightening the locking screw of the expandable vbr, it was noticed that the screwdriver tip had broken off.The broken off fragment remained in the head of the locking screw.The vbr was left implanted and the surgery was completed without further complications.The broken off fragment remained in the screw head and therefore in the patient's body.The suitability of the material of the fragment (stainless steel 1.4112) has not been evaluated for long-term tissue/bone contact.

• 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: 15691054
• Report Number: 3006493760-2022-00002
• Device Sequence Number: 6706835
• Product Code: MQP
• UDI-Device Identifier: 07640164847849
• UDI-Public: 07640164847849
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 10/28/2022

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: 10/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/28/2022
• 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: Other
• Patient Sex: Unknown