inforMED
InjuryMNI

EXCELLA-P

Received Apr 24, 2009 · Event occurred Mar 25, 2009

Report 3004719693-2009-00003 · MDR key 1369198

Device

Generic name

Pedicle Screw System

Manufacturer

Innovasis, Inc.

Model number

UNK

Product problems

  • Loose

Patient

Not reported

  • Unknown (for use when the patient's condition is not known)

Narrative

Additional Manufacturer Narrative

THE EVAL WAS INCONCLUSIVE AS TO WHY THE LOCKING CAP LOOSENED.

Description of Event or Problem

SALES REP CALLED AND REPORTED THAT LOCKING CAPS HAD COME LOOSE OVER TIME AFTER AN EARLIER SURGERY. MULTIPLE ATTEMPTS TO GET MORE DETAILED INFO WERE UNSUCCESSFUL.