Brand Name | MONT BLANC AND MONT BLANC MIS SPINAL SYSTEMS |
Type of Device | LOCKING SCREW |
Manufacturer (Section D) |
SPINEWAY |
7 allee moulin berger |
ecully, 69130 |
FR 69130 |
|
Manufacturer Contact |
héloïse
macaire
|
7 allée moulin berger |
ecully, 69130
|
FR
69130
|
|
MDR Report Key | 9694268 |
MDR Text Key | 189202016 |
Report Number | 3010758686-2020-00002 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K161387 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/22/2020 |
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 |
Health Professional
|
Device Expiration Date | 03/31/2024 |
Device Model Number | MIS1LS |
Device Catalogue Number | MIS1LS |
Device Lot Number | 5181904S |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/01/2020 |
Initial Date FDA Received | 02/11/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/17/2019 |
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) |
Required Intervention;
|
Patient Age | 40 YR |
|
|