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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARILIFT-LX; LUMBAR INTERBODY FUSION DEVICE
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VARILIFT-LX; LUMBAR INTERBODY FUSION DEVICE Back to Search Results
Catalog Number CIE3-12-28-00
Device Problem Migration (4003)
Patient Problem Aspiration/Inhalation (1725)
Event Date 02/07/2020
Event Type  malfunction  
Event Description
Implant explanted due to migration.Not product related.
 
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Brand Name
VARILIFT-LX
Type of Device
LUMBAR INTERBODY FUSION DEVICE
MDR Report Key9702202
MDR Text Key191585583
Report Number3008009850-2020-00001
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 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date02/20/2021
Device Catalogue NumberCIE3-12-28-00
Device Lot Number08151004
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/12/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
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