Brand Name | UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV |
Type of Device | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
150 minuteman road |
andover MA 01810 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
150 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 17653168 |
MDR Text Key | 322317220 |
Report Number | 3003604053-2023-00035 |
Device Sequence Number | 1 |
Product Code |
OWY
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K140300 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/25/2023 |
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 Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/09/2023
|
Initial Date FDA Received | 08/30/2023 |
Supplement Dates Manufacturer Received | 10/19/2023
|
Supplement Dates FDA Received | 10/25/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Other;
|
Patient Sex | Male |
|
|