Brand Name | SALVATION |
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 | 7406182 |
MDR Text Key | 104672461 |
Report Number | 7406182 |
Device Sequence Number | 1 |
Product Code |
KTT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/05/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/09/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | SEF20000 |
Device Catalogue Number | SEF20000 |
Other Device ID Number | SEF 20000 SALVATION WIRE 2MM |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/05/2018 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/05/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 39 YR |
Patient Weight | 109 |
|
|