Brand Name | FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
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 | 7038199 |
MDR Text Key | 92930834 |
Report Number | 1219602-2017-01426 |
Device Sequence Number | 1 |
Product Code |
MBI
|
UDI-Device Identifier | 03596010650528 |
UDI-Public | (01)03596010650528(17)210401(10)50594366 |
Combination Product (y/n) | N |
PMA/PMN Number | K093897 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
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 Expiration Date | 04/01/2021 |
Device Model Number | 72202901 |
Device Catalogue Number | 72202901 |
Device Lot Number | 50594366 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/16/2018 |
Initial Date Manufacturer Received |
11/16/2017 |
Initial Date FDA Received | 11/16/2017 |
Supplement Dates Manufacturer Received | 01/01/2018 02/26/2018
|
Supplement Dates FDA Received | 01/03/2018 02/28/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2017 |
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 | 72 YR |