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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 CIE3-11-24-00
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Pain (1994)
Date of Event 07/25/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the patient's fall during the initial weeks of recovery contributed to one of the varilift-lx implants migrating (the other remained in place) indicating that the migration was likely due to the impact of the fall.There is no indication of device malfunction or design issue that caused or contributed to this event.A revision surgery was performed to reposition the devices, no implants were removed.
 
Event or Problem Description
Report of varilift-lx revision surgery to reposition implant due to ongoing back pain after patient fall.
 
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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 Key6808623
Report Number3008009850-2017-00005
Device Sequence Number121855
Product Code MAX
UDI-Device Identifier00813210020078
UDI-Public00813210020078
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K151900
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 08/21/2017
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 Date12/30/2021
Device Model NumberCIE3-11-24-00
Device Lot NumberAJ024A
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 07/26/2017
Initial Report FDA Received Date08/21/2017
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;
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