SPATIALFRAME.COM SOFTWARE 71070401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-07 for SPATIALFRAME.COM SOFTWARE 71070401 manufactured by Smith & Nephew, Inc..

Event Text Entries

[94143250]
Patient Sequence No: 1, Text Type: N, H10


[94143271] It was reported after entering all parameters for the case, it was noticed that the software constructed the distal frame in an inverted fashion. The surgeon logged out of the software and logged back in and the issue was resolved. The issue had no affect on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2017-01197
MDR Report Key7095814
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-12-07
Date of Report2018-01-18
Date of Event2017-09-06
Date Mfgr Received2017-09-06
Date Added to Maude2017-12-07
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 FDA3
Event Location3
Manufacturer ContactMARKUS POETTKER
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPATIALFRAME.COM SOFTWARE
Generic NameSOFTWARE FOR DIAGNOSIS/TREATMENT
Product CodeOSN
Date Received2017-12-07
Catalog Number71070401
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.