Brand Name | HFN 10MMX16CM RIGHT |
Type of Device | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 8101222 |
MDR Text Key | 128253730 |
Report Number | 1020279-2018-02575 |
Device Sequence Number | 1 |
Product Code |
HSB
|
UDI-Device Identifier | 03596010543134 |
UDI-Public | 03596010543134 |
Combination Product (y/n) | N |
PMA/PMN Number | K043052 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
02/05/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/26/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 71701016R |
Device Lot Number | 17GM10252 |
Date Manufacturer Received | 11/01/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|