MalfunctionOSH

RESPONSE 5.5 SPINE SYSTEM

Received Sep 16, 2016 · Event occurred Jul 8, 2016

Report 3006460162-2016-00005 · MDR key 5957118

Device

Generic name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Manufacturer

Orthopediatrics Corp.

Catalog number

00-1003-4001

Product problems

Detachment Of Device Component
Detachment Of Device Component

Patient

14 YR

Congenital Defect/Deformity
Congenital Defect/Deformity

Narrative

Additional Manufacturer Narrative

REVISION SURGERY PERFORMED (B)(6) 2016 TO REATTACH ROD/PEDICLE SCREWS. OUTCOME POSITIVE.

Description of Event or Problem

DISTAL TWO SET SCREWS ON LEFT SPINE ROD AND SINGLE MOST DISTAL SET SCREW ON RIGHT OF SPINE ROD OF CONSTRUCT DISASSOCIATED FROM PEDICLE SCREW. DISCOVERED ON ROUTINE POST SURGICAL FOLLOW UP VISIT X-RAYS.