Brand Name | AEQUALIS FLEX REVIVE DISTAL STEM TRIAL 9DIA |
Type of Device | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
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 |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 19082152 |
MDR Text Key | 339846223 |
Report Number | 0001649390-2024-00159 |
Device Sequence Number | 1 |
Product Code |
HSD
|
UDI-Device Identifier | 00846832068678 |
UDI-Public | 00846832068678 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181420 |
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 |
04/10/2024 |
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 |
Health Professional
|
Device Catalogue Number | ARS742301 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/13/2024
|
Initial Date FDA Received | 04/10/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
Patient Sex | Female |
|
|