MAUDE Adverse Event Report: ICOTEC AG ICOTEC PEDICLE SYSTEM, NUT SCREW, TI; PEDICLE SCREW SYSTEM

Model Number	16-57-41000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was treated with the icotec pedicle system in a surgery ((b)(6) 2022).During a post-op check, it was detected that four nut screws had loosened.A revision surgery had to be carried out ((b)(6) 2023).During the revision surgery, it was realized that one pedicle screw had broken.The broken pedicle screw was not removed.The loosened nut screws were revised and the broken screw remained in the patient.No additional level was treated.
Additional Manufacturer Narrative
Analysis of the relevant production records did not identify any anomalies that could be a cause of the event.Investigation of historical adverse event data determined that icotec has become aware of one similar event with its pedicle system to date.

• Brand Name: ICOTEC PEDICLE SYSTEM, NUT SCREW, TI
• Common Device Name: PEDICLE SCREW 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: 17842817
• Report Number: 3006493760-2023-00003
• Device Sequence Number: 4401880
• Product Code: NKB
• UDI-Device Identifier: 07640140431994
• UDI-Public: 07640140431994
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/29/2023

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 Expiration Date: 06/13/2026
• Device Model Number: 16-57-41000
• Device Catalogue Number: 16-57-41000
• Device Lot Number: 20/02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/29/2023
• 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