FDA Adverse Event Malfunction Summary report: N

OPEN SPINE CLAMP, TITANIUM

MDR report key: 3771231 · Received April 24, 2014

Report

Report Number: 1723170-2014-00400
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: March 27, 2014
Report Date: November 9, 2015
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: HAW
PMA / PMN Number: K990214
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A MEDTRONIC REPRESENTATIVE REPORTED THAT SOMEONE AT THE SITE FIXED THE "BROKEN" CLAMP. IT SEEMS THE SCREW WAS NOT SEATED PROPERLY, THE THREADS WERE MISALIGNED. THE DEVICE IS WORKING FINE NOW AND THEY ARE NOT LOOKING TO REPLACE IT AT THIS TIME. NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative · 1

NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS. NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative · 1

CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

Description of Event or Problem · 1

A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SCREW ON THE SPINE CLAMP INSTRUMENT WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
250250	OPEN SPINE CLAMP, TITANIUM	NEUROLOGICAL STEREOTAXIC INSTRUMENT	HAW	MEDTRONIC NAVIGATION, INC.		121019

Patients

Seq	Age	Sex	Outcome	Treatment
1