Brand Name | INT HEX RC SCR BL 6.4X90 |
Type of Device | NAIL, 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 |
markus
poettker
|
1450 brooks road |
memphis, TN
|
|
MDR Report Key | 7224079 |
MDR Text Key | 98408162 |
Report Number | 1020279-2018-00084 |
Device Sequence Number | 1 |
Product Code |
JDS
|
UDI-Device Identifier | 03596010516749 |
UDI-Public | 03596010516749 |
Combination Product (y/n) | N |
PMA/PMN Number | K981529 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/10/2018 |
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 Catalogue Number | 71642390 |
Device Lot Number | 16BM17984 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/16/2018
|
Initial Date FDA Received | 01/29/2018 |
Supplement Dates Manufacturer Received | 01/16/2018
|
Supplement Dates FDA Received | 05/10/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 48 YR |
|
|