inforMED
InjuryOSH

RESPONSE 5.5/6.0 SPINE SYSTEM

Received Mar 15, 2017

Report 3006460162-2017-00314 · MDR key 6406440

Device

Generic name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Model number

00-1300-4001

Product problems

  • Device Issue
  • Device Issue

Patient

14 YR

  • Congenital Defect/Deformity
  • Congenital Defect/Deformity

Narrative

Description of Event or Problem

SURGEON ADVISED THAT HE HAD A PATIENT COME IN FOR ROUTINE FOLLOW UP AND PRESENTED WITH PAIN. X-RAY INDICATED THAT BOTH OF THE LATERAL CONNECTORS HAVE DISENGAGED FROM THE ILIAC SCREWS AT SOME POINT BETWEEN THE OFFICE VISIT AND THE SURGERY ((B)(6) 2016). REVISION SURGERY PERFORMED ON (B)(6) 2017: LATERAL CONNECTORS DISSOCIATED FROM THE 2 SCREWS AT THE BOTTOM OF THE CONSTRUCT. ONE SIDE WAS 5.5 COCR, THE OTHER SIDE WAS A 6.0 COCR ROD THE INITIAL SURGERY PREDATED SURGEON RETRAINING AND HIS USE OF TOWERS AT THE BOTTOM OF THE CONSTRUCT. REMOVED 2 SCREWS THAT WERE SPANNING THE SI JOINT. REMOVED ALL SET SCREWS AND RODS FROM THE CONSTRUCT. LEFT THE PEDICLE SCREWS IN PLACE. ADDED 2 7 X 25 POLY SCREWS IN S1 AND 28 X 80 POLY SCREWS IN S2 REPLACED THE ORIGINAL RODS WITH 5.5 TITANIUM RODS. UTILIZED TOWERS AT BOTTOM OF THE CONSTRUCT AND MOST OTHER PEDICLE SCREWS. JIMINYS USED TO HELP REDUCE THE ROD AND TOWERS FOR FINAL REDUCTION. USED 95INLB TORQUE DRIVERS TO SET THE SCREWS. UTILIZED A FIXED T-HANDLE TO PROVIDE ADDITIONAL TORQUE TO THE SET SCREWS.