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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
Device Problem Malposition of Device (2616)
Patient Problem Failure of Implant (1924)
Event Date 08/01/2018
Event Type  Injury  
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 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
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
Manufacturer (Section G)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
Manufacturer Contact
ronald smith
3 enterprise drive
suite 210
shelton, CT 06484
2039449494
MDR Report Key7790927
MDR Text Key117419600
Report Number3004638600-2018-00013
Device Sequence Number1
Product Code OVD
UDI-Device Identifier10840642108156
UDI-Public10840642108156
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161993
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date11/11/2019
Device Catalogue Number11-0953
Device Lot Number664P007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/01/2018
Initial Date FDA Received08/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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