MAUDE Adverse Event Report: ICOTEC AG ICOTEC ANTERIOR CERVICAL PLATE, 3 SEGMENTAL, 61 MM

Model Number	12-73-18-61
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
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 not become aware of any similar events with this devices to date.The investigation findings lead to the conclusion that the devices did not malfunction.Current information is insufficient to permit a valid conclusion of the cause of this event.Based on the information available, no corrective actions are proposed.A follow-up report will be submitted if additional relevant information becomes known.
Event or Problem Description
A patient was treated with an icotec kong-c vbr in a surgery on (b)(6) 2024 in switzerland.For anterior stabilistaion an icotec anterior cervical plate was used.Some days later (date not reported to manufacturer), it was detected that the anterior cervical plate has come loose caudally.A revision surgery had to be carried out ((b)(6) 2024).A new kong-c vbr was implanted and the anterior cervical plate was replaced with a longer plate and fixated with more screws.

• Brand Name: ICOTEC ANTERIOR CERVICAL PLATE, 3 SEGMENTAL, 61 MM
• Common Device Name: ICOTEC ANTERIOR CERVICAL PLATE, 3 SEGMENTAL, 61 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: 20744994
• Report Number: 3006493760-2024-00004
• Device Sequence Number: 8483684
• Product Code: KWQ
• UDI-Device Identifier: 07640140438320
• UDI-Public: 07640140438320
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K233215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: 10/18/2024
• Device Model Number: 12-73-18-61
• Device Catalogue Number: 12-73-18-61
• Device Lot Number: 20/02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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