It was reported that 2 plates broke post-operatively.Original surgery date was (b)(6) 2021 and a medial distal tibia plate, 8-hole and fibular plate, straight, 7-hole was implanted.Patient reported falling in the shower and upon return to the doctor on (b)(6) 2021, the break was discovered.A revision surgery was completed on (b)(6) 2021 where the hardware was removed.Paragon 28 clinical evaluation of the provided radiographic images shows severe dislocation of a transverse tibia fracture.The distal tibia plate is broken approximately at the level of the tibia fracture at a filled screw hole.The fibular plate is broken above the level of the tibia fracture at the screw hole above the tibia fracture.
|