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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WENZEL SPINE, INC. VARILIFT-LX; LUMBAR INTERBODY FUSION DEVICE
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WENZEL SPINE, INC. VARILIFT-LX; LUMBAR INTERBODY FUSION DEVICE Back to Search Results
Model Number CIE3-12-28-00
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Information (3190)
Date of Event 07/03/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.There is no report of patient pain or injury that led to the revision surgery.
 
Event or Problem Description
Varilift-lx revision surgery reported 1 month post index surgery.
 
Additional Manufacturer Narrative
Based on the information received to date, the root cause of the event is most likely due to improper placement or sizing of the device by the user during the index surgery.No evidence of a manufacturing or lot defect or device failure or malfunction was found.
 
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Brand Name
VARILIFT-LX
Common Device Name
LUMBAR INTERBODY FUSION DEVICE
Manufacturer (Section D)
WENZEL SPINE, INC.
1130 rutherford lane
suite 200
austin 78753
MDR Report Key6742372
Report Number3008009850-2017-00004
Device Sequence Number19149390
Product Code MAX
UDI-Device Identifier00813210020146
UDI-Public00813210020146
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K151900
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/30/2017
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
Operator of Device Physician
Device Expiration Date07/31/2021
Device Model NumberCIE3-12-28-00
Device Lot NumberAC008C
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2017
Supplement Date Received by Manufacturer07/05/2017
Initial Report FDA Received Date07/25/2017
Supplement Report FDA Received Date08/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
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