Brand Name | EVEREST ® SPINAL SYSTEM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION |
600 hope parkway se |
leesburg VA 20175 |
|
Manufacturer (Section G) |
K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION |
600 hope parkway se |
|
leesburg VA 20175 |
|
Manufacturer Contact |
eva
james
|
600 hope parkway se |
leesburg, VA 20175
|
5719192080
|
|
MDR Report Key | 8567622 |
MDR Text Key | 143661987 |
Report Number | 3004774118-2019-00048 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151727 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/30/2019 |
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 Catalogue Number | F2911-07540 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/09/2019 |
Initial Date FDA Received | 04/30/2019 |
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 Number | 1 |
Treatment | 1001-E5545 LOT UNKNOWN; 2901-10001 LOT UNKNOWN; F2911-06540 LOT UNKNOWN |
Patient Outcome(s) |
Required Intervention;
|