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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINE WAVE, INC. LEVA PX EXPANDABLE INTERBODY DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
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SPINE WAVE, INC. LEVA PX EXPANDABLE INTERBODY DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT Back to Search Results
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Code Available (3191)
Event Date 02/22/2019
Event Type  Injury  
Event Description
Approximately 5 months post-operatively, it was noted on imaging that the implants at the l4-5 level were not at full height.At six months post-operatively, a surgical procedure was performed at which time it was noted that the implants were not readily movable due to bone formation within the operative level.The surgeon chose not to remove the implants at this time.
 
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Brand Name
LEVA PX EXPANDABLE INTERBODY DEVICE
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
Manufacturer (Section D)
SPINE WAVE, INC.
3 enterprise drive
suite 210
shelton CT 06484
Manufacturer (Section G)
SPINE WAVE, INC.
3 enterprise drive
ste 210
shelton CT 06484
Manufacturer Contact
ronald smith
3 enterprise drive
ste 210
shelton, CT 06484
2039449494
MDR Report Key8405213
MDR Text Key138351261
Report Number3004638600-2019-00004
Device Sequence Number0
Product Code MAX
Reporter Country CodeUS
PMA/PMN Number
K141980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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