FDA Adverse Event Malfunction Summary report: N

NAV CD HORIZON SOLERA MAST 4.75 DRIVER

MDR report key: 3810297 · Received May 14, 2014

Report

Report Number: 1723170-2014-00474
Event Type: Malfunction
Date Received: May 14, 2014
Date of Event: April 14, 2014
Report Date: April 14, 2014
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: HAW
PMA / PMN Number: K050438
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. BASED ON THE TOXICOLOGICAL RISK ASSESSMENT OF THE MATERIAL IN THE DEVICE, THE POTENTIAL HEALTH RISK RESULTING FROM EXPOSURE TO A FRAGMENT OF THE DEVICE IS CONSIDERED TO BE NEGLIGIBLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS. NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative · 1

AS REPORTED, THE TIP OF THE DRIVER HAS BEEN TWISTED AND BROKEN OFF. OTHERWISE, THE DRIVER IS IN GOOD CONDITION. A REPLACEMENT DRIVER WAS SENT TO THE SITE FOR ISSUE RESOLUTION.

Description of Event or Problem · 1

A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINAL FUSION PROCEDURE, THE TIP OF THE DRIVER INSTRUMENT SHEARED OFF INTO THE SCREW DURING PLACEMENT OF THE FIRST SCREW. IT WAS REPORTED THAT SCLEROTIC BONE WAS A FACTOR. THE TIP OF THE DRIVER WAS LEFT IN THE SCREW WHICH REMAINED IN THE PATIENT. THE ROD AND SET SCREW WERE PLACED OVER IT. THE SURGEON USED A DIFFERENT DRIVER TO COMPLETE THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
288875	NAV CD HORIZON SOLERA MAST 4.75 DRIVER	NEUROLOGICAL STEREOTAXIC INSTRUMENT	HAW	MEDTRONIC NAVIGATION, INC.		120222

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR