InjuryOSH

RESPONSE 5.5/6.0 SPINE SYSTEM

Received Sep 23, 2016 · Event occurred Aug 25, 2016

Report 3006460162-2016-00006 · MDR key 5972740

Device

Generic name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Manufacturer

Orthopediatrics Corp.

Catalog number

UNKNOWN

Lot number

UNKNOWN

Product problems

Device Issue
Device Issue

Patient

Not reported

Congenital Defect/Deformity
Congenital Defect/Deformity

Narrative

Description of Event or Problem

SPINE ROD / PEDICLE SCREW DISASSOCIATED AS THE ROD WAS NOT SEATED IN THE SADDLE. TOWERS WERE USED AND SET SCREWS APPEARED FLUSH TO THE SURGEON INTRAOPERATIVELY. MALFUNCTION DISCOVERED DURING 9 MONTH OFFICE FOLLOW UP VISIT X-RAYS. REVISION SURGERY COMPLETED. NO PATIENT INFORMATION KNOWN. NO OTHER DETAILS AFTER MULTIPLE ATTEMPTS.