Brand Name | INFINITY® RESECTION ADJUSTMENT BLOCK |
Type of Device | SMALL JOINT INSTRUMENT |
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 |
|
1023 cherry road |
memphis, TN 38117
|
901451-631
|
|
MDR Report Key | 5685435 |
MDR Text Key | 47231542 |
Report Number | 1043534-2016-00034 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K123954 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/26/2016 |
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 | 33600030 |
Device Lot Number | 1333532 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/05/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/27/2016 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|