InjuryOSH

RESPONSE 5.5/6.0 SPINE SYSTEM

Received Dec 1, 2016 · Event occurred Nov 11, 2016

Report 3006460162-2016-01130 · MDR key 6138238

Device

Generic name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Manufacturer

Orthopediatrics Corp.

Catalog number

UNKNOWN

Lot number

UNKNOWN

Product problems

Detachment Of Device Component
Detachment Of Device Component

Patient

Not reported

Congenital Defect/Deformity
Congenital Defect/Deformity

Narrative

Description of Event or Problem

SPINE ROD / PEDICLE SCREW DISASSOCIATED. IT IS UNKNOWN IF TOWER INSTRUMENTS WERE UTILITIZED DURING INITIAL SURGERY. MALFUNCTION DISCOVERED 4 MONTHS POST OP. REVISION SURGERY COMPLETED WITH POSITIVE OUTCOME. NO PATIENT INFORMATION KNOWN.