Brand Name | SCR SFTSLK 2.0 PKG.8X25 STER |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
|
mansfield MA 02048 |
|
Manufacturer Contact |
jim
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 6800651 |
MDR Text Key | 83098166 |
Report Number | 1219602-2017-00939 |
Device Sequence Number | 1 |
Product Code |
HWC
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K921481 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
08/17/2017 |
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 Expiration Date | 05/31/2017 |
Device Catalogue Number | 7207260 |
Device Lot Number | 50423171 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/19/2017 |
Initial Date FDA Received | 08/17/2017 |
Date Device Manufactured | 06/21/2012 |
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 |
|
|