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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; LUMBAR INTERBODY FUSION DEVICE
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; LUMBAR INTERBODY FUSION DEVICE Back to Search Results
Catalog Number CIE3-12-24-00
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Aspiration/Inhalation (1725)
Event Date 06/21/2019
Event Type  malfunction  
Event Description
Varalift-lx implant removal surgery due to undersized initial implant.
 
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Type of Device
LUMBAR INTERBODY FUSION DEVICE
MDR Report Key8827689
MDR Text Key191585515
Report Number3008009850-2019-00001
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date02/09/2023
Device Catalogue NumberCIE3-12-24-00
Device Lot NumberBJ008D
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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