Brand Name | DART-FIRE |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
arlington TN 38002 |
|
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 | 12038059 |
MDR Text Key | 257716004 |
Report Number | 0001043534-2021-00108 |
Device Sequence Number | 1 |
Product Code |
HWC
|
UDI-Device Identifier | 00840420120342 |
UDI-Public | 00840420120342 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K082320 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/21/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/21/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | D1N30018S |
Device Catalogue Number | D1N30018S |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/25/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 42 YR |
Patient Weight | 104 |
|
|