Brand Name | AEQUALIS GLENOID AND REVERSED PIN |
Type of Device | SURGICAL ORTHOPEDIC INSTRUMENT |
Manufacturer (Section D) |
TORNIER S.A.S. |
161 rue lavoisier |
montbonnot saint-martin, 38330 |
FR 38330 |
|
Manufacturer Contact |
maud
andriollo
|
161 rue lavoisier |
montbonnot saint-martin, 38330
|
FR
38330
|
|
MDR Report Key | 8207829 |
MDR Text Key | 131768690 |
Report Number | 3000931034-2019-00004 |
Device Sequence Number | 1 |
Product Code |
HWE
|
UDI-Device Identifier | 03700386931796 |
UDI-Public | 03700386931796 |
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 |
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 |
No Information
|
Device Expiration Date | 05/23/2023 |
Device Model Number | DIAM.2.5 MM LENGTH 200MM |
Device Catalogue Number | DWD063 |
Device Lot Number | 4281AT |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/05/2018 |
Initial Date FDA Received | 01/02/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/23/2018 |
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) |
Other;
|
Patient Age | 77 YR |