Brand Name | SALVATION EXTERNAL FIXATION SYSTEM |
Type of Device | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Manufacturer (Section D) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
arlington TN 38002 |
|
MDR Report Key | 8412580 |
MDR Text Key | 138537617 |
Report Number | 1043534-2019-00033 |
Device Sequence Number | 1 |
Product Code |
KTT
|
Combination Product (y/n) | N |
PMA/PMN Number | K150004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
02/11/2019 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | SEF25000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/08/2019 |
Was the Report Sent to FDA? |
No
|
Event Location |
Outpatient Treatment Facility
|
Initial Date Manufacturer Received |
02/11/2019 |
Initial Date FDA Received | 03/12/2019 |
Supplement Dates Manufacturer Received | 09/11/2019
|
Supplement Dates FDA Received | 09/26/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|