Brand Name | LATITUDE EV ULNAR STEM |
Type of Device | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED |
Manufacturer (Section D) |
TORNIER INC |
10801 nesbitt avenue s |
bloomington MN 55437 |
|
Manufacturer (Section G) |
TORNIER INC |
10801 nesbitt avenue s |
|
bloomington MN 55437 |
|
Manufacturer Contact |
nathe
hendricks
|
10801 nesbitt avenue s |
bloomington, MN 55437
|
9524267600
|
|
MDR Report Key | 12327938 |
MDR Text Key | 266837196 |
Report Number | 3004983210-2021-00063 |
Device Sequence Number | 1 |
Product Code |
JDC
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/16/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/16/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | UNK_WTB |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/19/2021 |
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 Outcome(s) |
Required Intervention;
|
|
|