It was reported via (b)(6) clinical study that a patient presented with progressive pain and implant prominence and skin breakthrough approximately 3 years post-operatively.Radiographs revealed acute loosening (proximally, midpoint, and distally) and infection of the patient's metalwork.Revision surgery was performed where all the implants were removed.This report captures the mesa rail.
|
Visual, functional, dimensional, and material analysis inspections could not be performed as the device(s) were not available.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not obtained.The patient was implanted from t3 to l2 with mesa hardware, in 2018, without complication.Clinically the patient appeared fused.In (b)(6) 2021, the patient experienced discomfort.No migrations were observed.In (b)(6) 2021, the patient presented with acute loosening and infection of metalwork.Following radiographs showed screws loosening at the proximal, midpoint, and distal levels.The patient was revised to remove the hardware.Culture samples reveal that the patient's infection was enterobacter cloacae.Consultation with hcp suggests that implant loosening and infection can be tied together, as infection compromises fusion environment, subsequently leading to implant loosening.Some common ways of enterobacter cloacae contraction are from the gi tract, skin, and the urinary tract.From the mesa surgical technique, "potential adverse consequences include, but are not limited to pseudoarthrosis, loosening, bending, cracking or fracture of the components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contradictions, or warnings and precautions; infections possibly requiring removal of devices." from the provided information and consultation with hcp, the likely cause of the reported screw migrations can be attributed to late infection.
|
It was reported via mesa clinical study that a patient presented with progressive pain and implant prominence and skin breakthrough approximately 3 years post-operatively.Radiographs revealed acute loosening (proximally, midpoint, and distally) and infection of the patient's metalwork.Revision surgery was performed where all the implants were removed.This report captures the mesa rail.
|