Brand Name | AXLE INTERSPINOUS FUSION SYSTEM |
Type of Device | SPINOUS PROCESS PLATE |
Manufacturer (Section D) |
X-SPINE SYSTEMS, INC. |
664 cruiser lane |
belgrade, mt |
|
Manufacturer (Section G) |
X-SPINE SYSTEMS, INC. |
664 cruiser lane |
|
belgrade, mt |
|
Manufacturer Contact |
casey
ming
|
664 cruiser lane |
belgrade, mt
|
3880480112
|
|
MDR Report Key | 9948767 |
MDR Text Key | 199662717 |
Report Number | 3005031160-2020-00011 |
Device Sequence Number | 1 |
Product Code |
PEK
|
UDI-Device Identifier | M697X06003201 |
UDI-Public | M697X06003201 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130438 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | X060-0320 |
Device Lot Number | 062236 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/31/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/30/2020 |
Initial Date FDA Received | 04/10/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/03/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|