MAUDE Adverse Event Report: ICOTEC AG ICOTEC VADER PEDICLE SYSTEM; PEDICLE SCREW SYSTEM

Model Number 16-60-41000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/08/2022

Event Type  Injury  

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 event with its pedicle system to date.The screw drivers with torque limiting function used in the surgery for tightening the nut screws were returned to icotec.Investigation of the devices showed that they are within their specification and function as intended.It can therefore be concluded that the screw drivers were not the cause of the adverse event.According to our current knowledge, the event has not resulted in any adverse postoperative health consequences for the patient.

Event Description

A patient was treated with the icotec pedicle system in a first surgery (b)(6) 2021).In a second surgery (b)(6) 2022) the icotec pedicle system was extended due to an additional corpectomy treatment (vbr, not icotec product).During a post-op check after the second surgery, it was detected that one nut screw had completely loosened.A revision surgery had to be carried out (b)(6) 2022).During the revision, it was realized that six of eight nut screws had become loose.The icotec pedicle system was replaced.During replacement, one of the pedicle screws of the first surgery broke when it was unscrewed, due to bone ingrowth.Broken pedicle screw could be removed completely.

• Brand Name: ICOTEC VADER PEDICLE SYSTEM
• 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: 15504553
• MDR Text Key: 300796799
• Report Number: 3006493760-2022-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 16-60-41000
• Device Catalogue Number: 16-60-41000
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2022
• Initial Date FDA Received: 09/29/2022
• 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
• Removal/Correction Number: N.A.
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention