Brand Name | EASYFUSE¿ |
Type of Device | STAPLE, FIXATION, BONE |
Manufacturer (Section D) |
WRIGHT MEDICAL TECHNOLOGY INC |
1023 cherry rd |
memphis TN 38117 |
|
Manufacturer (Section G) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
|
arlington TN 38002 |
|
Manufacturer Contact |
nathe
hendricks
|
1023 cherry rd |
memphis, TN 38117
|
9014516318
|
|
MDR Report Key | 13261444 |
MDR Text Key | 284373396 |
Report Number | 3010667733-2022-00015 |
Device Sequence Number | 1 |
Product Code |
JDR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K203832 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/16/2022 |
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 | FFS42520 |
Device Lot Number | 1719962 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/05/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/17/2021 |
Initial Date FDA Received | 01/14/2022 |
Supplement Dates Manufacturer Received | 02/18/2022
|
Supplement Dates FDA Received | 03/16/2022
|
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 73 YR |
Patient Sex | Male |
|
|