Brand Name | KIT 5.5MM FP SUT ANC SL ACH TENDON RE |
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 |
james
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 7051313 |
MDR Text Key | 92974731 |
Report Number | 1219602-2017-01454 |
Device Sequence Number | 1 |
Product Code |
MBI
|
UDI-Device Identifier | 00885554029970 |
UDI-Public | (01)00885554029970(17)210722(10)50668015 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123579 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/04/2017 |
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 | 07/22/2021 |
Device Catalogue Number | 72203798 |
Device Lot Number | 50668015 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/30/2017 |
Initial Date FDA Received | 11/21/2017 |
Supplement Dates Manufacturer Received | 10/30/2017
|
Supplement Dates FDA Received | 12/04/2017
|
Date Device Manufactured | 06/06/2017 |
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 |
|
|