Medtronic—CD HORIZON Solera Spinal System Screws: May Be Laser Marked with Incorrect Diameter

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In a July 5, 2018, Urgent Voluntary Market Removal letter submitted by an ECRI Institute member hospital, Medtronic states that the above screws may have been incorrectly laser marked on the screw head and on the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements. Medtronic also states that the risk associated with this problem is a likelihood that the implanted screw is undersized to the intent of the construct. If discovered preoperatively or intraoperatively, a minor adjustment to surgery because of prescription of a replacement may be necessary, resulting in surgical delay. Intraoperatively, the hardware may be loose depending on the size of the tap used. Long-term harm includes potential construct failure, necessitating revision surgery. As a result, adverse clinical consequences are unlikely because the screw confirmation tool is included within each set, which identifies screw length and screw diameter. The crown of the bone screw is color-coded to indicate each size diameter available in the implant set. Surgeons use tactile feel when inserting pedicle screws. It is not uncommon for a surgeon to change screw selection based on the amount of resistance (torque) felt while placing a pedicle screw. If the surgeon encounters line-to-line tapping, the surgeon may observe less than desired resistance torque. Medtronic further states that it has received no...