Brand Name | VERSE CORRECTION KEY |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD |
Manufacturer (Section D) |
MEDOS INTERNATIONAL SÃ RL CH |
chemin-blanc 38 |
le locle 02400 |
SZ
02400 |
|
Manufacturer (Section G) |
BRIDGEWATER DISTRIBUTION |
50 scotland boulevard |
|
bridgewater MA 02324 |
|
Manufacturer Contact |
kara
ditty-bovard
|
325 paramount drive |
raynham, MA 02767
|
6103142063
|
|
MDR Report Key | 10907080 |
MDR Text Key | 229474671 |
Report Number | 1526439-2020-02298 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K142185 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
10/29/2020 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 11/25/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 199721000 |
Device Catalogue Number | 199721000 |
Device Lot Number | 217159 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/19/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 01/22/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/21/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Unkown
|