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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 VELYS HIP NAV TOWER SOFTWARE SOFTWARE AS A MEDICAL DEVICE

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DEPUY ORTHOPAEDICS, INC. 1818910 VELYS HIP NAV TOWER SOFTWARE SOFTWARE AS A MEDICAL DEVICE Back to Search Results
Catalog Number 451580051
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Please note that a physical manufacturer in section g of this report was not provided as this is a software as a medical device product. This software is sold and distributed as a stand alone software and is not associated with hardware. The reason for non-evaluation was marked as other due to reported product is software. An investigation was performed by interview. Investigation summary: an investigation confirmed the reported event. Depuy considers the investigation closed. Should additional info be received, the investigation will be re-opened as necessary.
 
Event Description
It was reported that the issue: one trial analysis chart does not correctly reflect the change to leg length when changing between proximal body heights.
 
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Brand NameVELYS HIP NAV TOWER SOFTWARE
Type of DeviceSOFTWARE AS A MEDICAL DEVICE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10655439
MDR Text Key211857090
Report Number1818910-2020-21837
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number451580051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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