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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. LEVA ANTERIOR INTERBODY SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE
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SPINE WAVE, INC. LEVA ANTERIOR INTERBODY SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 11-0953
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event was confirmed by radiograph.Device was not returned therefore no evaluation could be performed.A review of the device history record found device met all specifications for release.
 
Event or Problem Description
The surgeon reported that one screw in an anterior cage construct was out of position as noted on radiograph approximately 6 weeks following an anterior lumbar interbody fusion procedure.A reoperation was performed to replace the construct.
 
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Brand Name
LEVA ANTERIOR INTERBODY SYSTEM
Common Device Name
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
MDR Report Key7790927
Report Number3004638600-2018-00013
Device Sequence Number19154366
Product Code OVD
UDI-Device Identifier10840642108156
UDI-Public10840642108156
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K161993
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/01/2018
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 Health Professional
Device Expiration Date11/11/2019
Device Catalogue Number11-0953
Device Lot Number664P007
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/01/2018
Initial Report FDA Received Date08/16/2018
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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