InjuryMNI
EXCELLA-P
Received Apr 25, 2009 · Event occurred Oct 29, 2008
Report 3004719693-2009-00001 · MDR key 1369127
Device
Generic name
Pedicle Screw System
Manufacturer
Innovasis, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Detachment Of Device Component
Patient
42 YR
- Surgical procedure, repeated
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
DISTRIBUTOR'S REP TELEPHONED ON THE EVENT DATE, AND REPORTED THAT SURGEON HAD OBSERVED BY X-RAY THAT A LOCKING CAP HAD COME OFF FROM A PEDICLE SCREW CONSTRUCT. SURGERY WAS SCHEDULED TO MAKE A REVISION OF THE CONSTRUCT. THE EVENT WAS CLASSIFIED AS A REPORTABLE EVENT AND FORMS WERE SENT TO THE REP TO PROVIDE DETAILS FOR THE REPORT.
Additional Manufacturer Narrative
THE EVALUATION WAS INCONCLUSIVE AS TO WHY THE LOCKING CAP WAS LOOSE.