OtherMOP

INFIX

Received May 11, 2005 · Event occurred Apr 11, 2005

Report 1649384-2005-00031 · MDR key 601897

Device

Generic name

Strut, Large, 14mm

Manufacturer

Abbott Spine

Model number

Catalog number

1804-514

Lot number

Product problems

Explanted
Replace
Failure to Align

Patient

Surgery, prolonged
Surgical procedure

Narrative

Description of Event or Problem

DOCTOR IMPLANTED AN INFIX CAGE. THE PT WAS TURNED OVER TO IMPLANT POSTERIOR SCREWS. A FINAL FILM WAS TAKEN FOR SCREW PLACEMENT. AT THAT TIME IT WAS NOTICED THAT ONE OF THE STRUTS IN THE INFIX CAGE WAS NOT PROPERLY ALIGNED. PT WAS THEN TURNED BACK OVER AND REOPENED TO REMOVE ANY REPLACE THE DEVICE. THIS EVENT CAUSED A SURGICAL DELAY OF MORE THAN 30 MINUTES.

Remedial action

Replace