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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE SPINE, INC. LIFE SPINE AVATAR

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LIFE SPINE, INC. LIFE SPINE AVATAR Back to Search Results
Model Number 148-003
Device Problem Osseointegration Problem (3003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2019
Event Type  malfunction  
Manufacturer Narrative
Device was not returned unable to complete a full analysis.
 
Event Description
It was reported 1 month post operatively, following surgery that set screw came out of the right l5 pedicle.
 
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Brand NameLIFE SPINE
Type of DeviceAVATAR
Manufacturer (Section D)
LIFE SPINE, INC.
13951 s. quality drive
huntley IL 60142
Manufacturer (Section G)
LIFE SPINE, INC.
13951 s. quality drive
huntley IL 60142
Manufacturer Contact
angela batker
13951 s. quality drive
huntley, IL 60142
MDR Report Key8428112
MDR Text Key139231332
Report Number3004499989-2019-00002
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00190837000943
UDI-Public00190837000943
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111953
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number148-003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/18/2019 Patient Sequence Number: 1
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