Brand Name | AEQUALIS HUMERAL NAIL SYSTEM |
Type of Device | INTRAMEDULLARY NAIL |
Manufacturer (Section D) |
TORNIER INC. |
10801 nesbitt avenue s |
bloomington MN 55437 |
|
Manufacturer Contact |
matt
kennedy
|
10801 nesbitt ave s |
bloomington, MN 55437
|
9526837482
|
|
MDR Report Key | 8132540 |
MDR Text Key | 129305698 |
Report Number | 3004983210-2018-00077 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K082754 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
study |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/05/2018 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 0020600 |
Device Lot Number | CA5207811 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/30/2018 |
Initial Date FDA Received | 12/05/2018 |
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 Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |