MAUDE Adverse Event Report: ICOTEC AG ICOTEC PEDICLE SYSTEM, SCREW, CARBON/PEEK; PEDICLE SCREW SYSTEM

Model Number 16-6022-55540, 16-6022-55545

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Analysis of the relevant production records did not identify any anomalies that could be a cause of the events.During the investigation it was revealed that not the icotec specific taps were used for tapping.Taps of a third party manufacturer were used.According to the ifu only icotec specific instruments are intended for use with the icotec implants.Icotec has requested the hospital to return the affected implants, but the hospital will not release them.Neither the device nor applicable images were provided to icotec for evaluation.Based on the results of the investigations and the available information, it is not possible to determine the definite root cause for the incident.

Event Description

A patient was treated with the icotec pedicle system in a surgery (8.Dez 2022).During a post-op check, it was detected that one of the vertebral bodies collapsed and three pedicle screws out of nine have broken at the screw head.A revision surgery had to be carried out (18.Nov 2023).During the revision surgery, it was realized that one additional screw had become loose.

• Brand Name: ICOTEC PEDICLE SYSTEM, SCREW, CARBON/PEEK
• Type of Device: 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: 18238925
• MDR Text Key: 329386866
• Report Number: 3006493760-2023-00004
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-6022-55540, 16-6022-55545
• Device Catalogue Number: 16-6022-55540, 16-6022-55545
• Device Lot Number: UNCLEAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention