MAUDE Adverse Event Report: ICOTEC AG ICOTEC TORQUE WRENCH; PEDICLE SCREW SYSTEM

Model Number	42-702
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user implanted icotec implant devices (pedicle screws and nut screws) together with pedicle rods from another manufacturer.This is a case of abnormal (off-label) use.During the investigation of the devices involved, it was detected that the torque wrench limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly.Due to the malfunction, the nut screws may not have been tightened sufficiently and therefore became loose.The inspection of the device at the supplier showed an untight welding seam, which allowed liquids (e.G.Cleaning or disinfection agents) and/or steam to enter the inside of the torque wrench during processing.Thus leading to corrosion of the mechanical components leading to malfunction of the torque limiting function.To inform users of devices that may also be affected and to prevent their further use, a recall is being carried out.
Event or Problem Description
A patient was treated with the icotec pedicle system in a surgery.During a post-op check 7-10 days after, it was detected that six out of eight nut screws had loosened.A revision surgery had to be carried out.The loosened nut screws and the pedicle screws were removed and revised.

• Brand Name: ICOTEC TORQUE WRENCH
• 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: 18266154
• Report Number: 3006493760-2023-00005
• Device Sequence Number: 7900142
• Product Code: NKB
• UDI-Device Identifier: 07640140431994
• UDI-Public: 07640140431994
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K222789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42-702
• Device Catalogue Number: 42-702
• Device Lot Number: N.A.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2023
• Initial Report FDA Received Date: 12/05/2023
• 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: Required Intervention
• Patient Sex: Unknown