• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 2.25 MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 2.25 MM PEDICLE PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733457
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2015
Event Type  malfunction  
Manufacturer Narrative
The site declined to provide patient information, per (b)(4) privacy laws. Device lot number not available. Device manufacturing date is dependent on lot number, therefore, unavailable. No parts have been received by manufacturer for analysis. No further issues have been reported. Part not received by manufacturer.
 
Event Description
A medtronic representative reported that, while in a spine procedure, the surgeon used the 2. 25 millimeter pedical probe on sacral region. While using the probe, the tip bent. The surgeon opted to continue and completed the procedure with the use of the navigation system. There was no delay of therapy. There was no impact on patient outcome.
 
Manufacturer Narrative
Lot number and device manufacture date provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2.25 MM PEDICLE PROBE
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
amos jarrette
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key5377536
MDR Text Key36347023
Report Number1723170-2016-00069
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9733457
Device Lot Number080722
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-