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 | 5742690 |
MDR Text Key | 47962285 |
Report Number | 1043534-2016-00044 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/20/2016 |
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 |
Other
|
Device Catalogue Number | 3360-0030 |
Device Lot Number | 131 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/23/2016 |
Initial Date FDA Received | 06/22/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/19/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|