Brand Name | D-RAD TI 2.4MM X 10MM CORTEX SCREW T7 S-T |
Type of Device | PLATE, FIXATION, BONE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
claudia
odoy
|
1450 brooks road |
memphis, TN 38116
|
0416283206
|
|
MDR Report Key | 5978150 |
MDR Text Key | 55935290 |
Report Number | 1020279-2016-00747 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132296 |
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 |
Report Date |
09/16/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/26/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/03/2015 |
Device Catalogue Number | 74682410 |
Device Lot Number | 14JM01040 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/16/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/03/2014 |
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 Outcome(s) |
Other;
|
|
|