Brand Name | ULTRA FAST-FIX ASSEMBLY - CURVED |
Type of Device | STAPLE, 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 w william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 7199450 |
MDR Text Key | 97770860 |
Report Number | 1219602-2018-00096 |
Device Sequence Number | 1 |
Product Code |
JDR
|
Combination Product (y/n) | N |
PMA/PMN Number | K972326 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign,health profe |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/28/2018 |
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 Catalogue Number | 72201491 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/08/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/16/2018 |
Initial Date FDA Received | 01/17/2018 |
Supplement Dates Manufacturer Received | 01/25/2018 02/26/2018
|
Supplement Dates FDA Received | 02/03/2018 02/28/2018
|
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 |
Patient Age | 56 YR |
|
|