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 Key | 7790927 |
MDR Text Key | 117419600 |
Report Number | 3004638600-2018-00013 |
Device Sequence Number | 1 |
Product Code |
OVD
|
UDI-Device Identifier | 10840642108156 |
UDI-Public | 10840642108156 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161993 |
Number of Events Reported | 1 |
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 Date | 11/11/2019 |
Device Catalogue Number | 11-0953 |
Device Lot Number | 664P007 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/01/2018 |
Initial Date FDA Received | 08/16/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/16/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|