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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPATIALFRAME.COM SOFTWARE; SOFTWARE FOR DIAGNOSIS/TREATMENT
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SMITH & NEPHEW, INC. SPATIALFRAME.COM SOFTWARE; SOFTWARE FOR DIAGNOSIS/TREATMENT Back to Search Results
Catalog Number 71070401
Device Problem Application Program Problem (2880)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2019
Event Type  malfunction  
Event Description
It was reported that just prior to the start of the case, surgeon noticed the site just showed a blank screen.The case went ahead but without being able to use the spatial frame software.The problem was rectified and a residual correction was ran at the end of the case.Event did not result in any adverse outcome for the patient.
 
Manufacturer Narrative
Correct address and country added.
 
Manufacturer Narrative
The associated complaint device was not returned.The failure was evaluated by our development team and found to be an anomaly.The website could not be accessed until the hosting company restarted the server and was then able to log in.We have no evidence to suggest this was the fault of the device.Without the actual device involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
SPATIALFRAME.COM SOFTWARE
Type of Device
SOFTWARE FOR DIAGNOSIS/TREATMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN
MDR Report Key8433768
MDR Text Key139236775
Report Number1020279-2019-01103
Device Sequence Number1
Product Code OSN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71070401
Date Manufacturer Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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