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.
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