FDA Adverse Event Injury Summary report: N

EXCELLA-P

MDR report key: 1369129 · Received April 25, 2009

Report

Report Number: 3004719693-2009-00002
Event Type: Injury
Date Received: April 25, 2009
Date of Event: February 10, 2009
Report Date: April 25, 2009
Manufacturer: INNOVASIS, INC.
Product Code: MNI
PMA / PMN Number: K071921
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS WAS ORIGINALLY NOT CLASSIFIED AS AN MDR, BASED ON ABSENCE OF SURGICAL INTERVENTION AND THE CONCEPT OF A REDUNDANT SYSTEM (TWO RODS) AND, THAT THIS IS A KNOWN POTENTIAL OCCURRENCE AFTER A PERIOD OF TIME. THE CLASSIFICATION WAS REVIEWED AND REVISED IN 2009, BECAUSE OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INITIATED IN RESPONSE TO AN ASSESSEMENT AUDIT (FOR ISO REGISTRATION) CONDUCTED. DR CAME TO OUR FACILITY TWICE TO HELP US CONSIDER VARIATION IN TECHNIQUE THAT COULD POSSIBLY CONTRIBUTE TO A LOCKING CAPS LOOSENING OVER TIME. AFTER HIS FIRST VISIT, HAVING REVIEWED HIS TECHNIQUES ON OUR BENCH TOP MODELS, WE WERE SOMETIMES ABLE TO CREATE CONSTRUCTS RESULTING IN A LOOSE LOCKING CAP. ON HIS SECOND VISIT, APRIL 22, 2009, WE AGAIN WERE ABLE TO USE VARIATIONS ON HIS TECHNIQUE THAT COULD SOMETIMES RESULT IN A POTENTIALLY LOOSE SCREW. WE BELIEVE THAT UNDERSTANDING THE MECHANISM OF THE POTENTIAL FAILURE ALLOWS THE USER TO PREVENT ITS OCCURRENCE.

Description of Event or Problem · 1

APPROXIMATELY 3 MONTHS AFTER SURGERY, A ROUTINE FOLLOW-UP X-RAY REVEALED A LOOSE LOCKING CAP ASSOCIATED WITH THE PEDICLE SCREW CONSTRUCT. COPIES OF THE X-RAY PICTURE WERE PROVIDED WITH THE COMPLAINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXCELLA-P	PEDICLE SCREW SYSEM	MNI	INNOVASIS, INC.	NOT REPORTED	NOT REPORTED

Patients

Seq	Age	Sex	Outcome	Treatment
1				RODS\| PEDICLE SCREWS\| LOCKING CAPS