BAXANO NEURAL LOCALIZATION PROBE FG0440-03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-04-09 for BAXANO NEURAL LOCALIZATION PROBE FG0440-03 manufactured by Baxano, Inc..

Event Text Entries

[1189633] During a decompression procedure at the l5/s1 level, the physician withdrew device to reposition. Upon withdrawal, he observed that the distal tip was detached from the neural localization probe. He did lateral and a/p fluoroscopy to visualize the tip and found it just lateral of midline. He successfully retrieved tip without further resection. In the evening, the company spoke to the physician. No additional clinical sequelae was reported as a result of the device malfunction.
Patient Sequence No: 1, Text Type: D, B5


[8283024] The device was inspected. Manufacturing and material records were evaluated and components and processes were within specification. Design is being evaluated and corrective action initiated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006324586-2009-00004
MDR Report Key1429547
Report Source07
Date Received2009-04-09
Date of Report2009-04-08
Date of Event2009-03-19
Date Mfgr Received2009-03-19
Device Manufacturer Date2009-03-01
Date Added to Maude2009-10-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactPATTY HEVEY
Manufacturer Street2660 MARINE WAY, SUITE B
Manufacturer CityMOUNTAIN VIEW CA 94043
Manufacturer CountryUS
Manufacturer Postal94043
Manufacturer Phone6509371400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBAXANO NEURAL LOCALIZATION PROBE
Generic NameNEURAL LOCALIZATION PROBE
Product CodeGZI
Date Received2009-04-09
Catalog NumberFG0440-03
Lot Number09031001
Device Expiration Date2009-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXANO, INC.
Manufacturer Address2660 MARINE WAY, SUITE B MOUNTAIN VIEW CA 94043 US 94043


Patients

Patient NumberTreatmentOutcomeDate
10 2009-04-09

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