InjuryOSH
RESPONSE 5.5/6.0 SPINE SYSTEM
Received Sep 13, 2016 · Event occurred Aug 17, 2016
Report 3006460162-2016-00004 · MDR key 5945569
Device
Generic name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Manufacturer
Orthopediatrics Corp.Catalog number
00-1300-6051
Product problems
- Malposition of Device
- Malposition of Device
Patient
16 YR
- Congenital Defect/Deformity
- Congenital Defect/Deformity
Narrative
Description of Event or Problem
USE ERROR BY SURGEON. SPINE ROD CUT TOO SHORT FOR FINAL CONSTRUCT. MOST DISTAL SCREW DID NOT HAVE ADEQUATE PURCHASE ON SPINE ROD AS SEEN IN X-RAY. DISCOVERED ROD/SCREW DISASSOCIATION ON FOLLOW UP VISIT.