Brand Name | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Type of Device | HFN 10MMX16CM RIGHT |
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 |
markus
poettker
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
|
MDR Report Key | 6600320 |
MDR Text Key | 76234631 |
Report Number | 1020279-2017-00377 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043052 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/28/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | 71701016R |
Device Catalogue Number | 71701016R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/03/2017 |
Initial Date FDA Received | 05/31/2017 |
Supplement Dates Manufacturer Received | 05/03/2017
|
Supplement Dates FDA Received | 09/28/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|