Brand Name | REVERSED II SCREW FOR GLENOID SPHERE EXTRACTOR |
Type of Device | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Manufacturer (Section D) |
TORNIER S.A.S. |
161 rue lavoisier |
montbonnot saint-martin 38330 |
FR 38330 |
|
Manufacturer (Section G) |
TORNIER S.A.S. |
161 rue lavoisier |
|
montbonnot saint-martin 38330 |
FR
38330
|
|
Manufacturer Contact |
nathe
hendricks
|
1023 cherry rd |
memphis, TN 38117
|
9014516318
|
|
MDR Report Key | 12344856 |
MDR Text Key | 267350801 |
Report Number | 3000931034-2021-00314 |
Device Sequence Number | 1 |
Product Code |
HWB
|
UDI-Device Identifier | 03700386972010 |
UDI-Public | 03700386972010 |
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
08/19/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | MWD148 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/22/2021
|
Initial Date FDA Received | 08/19/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |