Brand Name | TWINFIX TI 2.8 ULTRABRAID |
Type of Device | STAPLE, FIXATION, BONE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
MDR Report Key | 8541879 |
MDR Text Key | 142883896 |
Report Number | 1219602-2019-00454 |
Device Sequence Number | 1 |
Product Code |
JDR
|
UDI-Device Identifier | 03596010584472 |
UDI-Public | 03596010584472 |
Combination Product (y/n) | N |
PMA/PMN Number | K972326 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
07/11/2019 |
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 | 10/12/2022 |
Device Catalogue Number | 72200750 |
Device Lot Number | 50690426 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/08/2019 |
Initial Date Manufacturer Received |
03/30/2019 |
Initial Date FDA Received | 04/23/2019 |
Supplement Dates Manufacturer Received | 05/15/2019 07/11/2019
|
Supplement Dates FDA Received | 05/16/2019 07/11/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|