Brand Name | TWIST DRILL FLEX CRVD FOR 2.3 SA |
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 w. william cannon |
austin, TX 78735
|
|
MDR Report Key | 6617285 |
MDR Text Key | 76968666 |
Report Number | 1219602-2017-00576 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
PMA/PMN Number | K102660 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/28/2017 |
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 Catalogue Number | 72203160 |
Device Lot Number | 50656837 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/11/2017 |
Initial Date FDA Received | 06/07/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/28/2017
|
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 |
|
|