XKNIFE 5.0 INSTALL KIT XK5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-18 for XKNIFE 5.0 INSTALL KIT XK5 manufactured by Integra, Burlington.

Event Text Entries

[2157184] A (b)(4) software was described to have the following issues: there were two issues that occurred during the case but only one was responsible for the case being postponed. The two issues were: preplanned contours on the mri image set appeared shifted in the coronal and sagittal reconstructed image sets in the contouring mode. (contours were fine in the planning mode. ) they were able to work around this problem and continue with the case. The software would crash when they typed a value into a field and then hit the tab or enter key. After the software crashed a few times, it was decided to cancel the case.
Patient Sequence No: 1, Text Type: D, B5


[9396108] The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222895-2011-00013
MDR Report Key2258230
Report Source05
Date Received2011-08-18
Date of Report2011-08-18
Date Mfgr Received2011-07-20
Date Added to Maude2012-06-21
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 ContactLINDA SERENTINO
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099365560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXKNIFE 5.0 INSTALL KIT
Generic NameNEURO
Product CodeKPQ
Date Received2011-08-18
Catalog NumberXK5
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA, BURLINGTON
Manufacturer AddressBURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-18

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