Brand Name | CLOSED CERVICAL CAGE 14X15.5 H6MM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
LDR MÉDICAL |
quartier europe de l¿ouest |
5, rue de berlin |
sainte-savine, na 10300 |
FR 10300 |
|
Manufacturer (Section G) |
LDR MÉDICAL |
quartier europe de l¿ouest |
5, rue de berlin |
sainte-savine, na 10300 |
FR
10300
|
|
Manufacturer Contact |
kim
martinez
|
10225 westmoor dr. |
na |
westminster, CO 80021
|
3035144809
|
|
MDR Report Key | 16973591 |
MDR Text Key | 315786589 |
Report Number | 3004788213-2023-00051 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 03662663021432 |
UDI-Public | (01)03662663021432(10)31944R2 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K121103 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/22/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/22/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | MC322P |
Device Lot Number | 31944R215 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/27/2023 |
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) |
Other;
|