Brand Name | EXP DI FAR SCREWS 6.00 X 45 |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE |
Manufacturer (Section D) |
MEDOS INTERNATIONAL SÃ RL CH |
chemin-blanc 38 |
le locle 02400 |
SZ 02400 |
|
Manufacturer (Section G) |
MEDOS INT SPINE |
chemin blanc 38 |
|
le locle |
SZ
|
|
Manufacturer Contact |
jason
busch
|
325 paramount drive |
raynham, MA 02767
|
5088808100
|
|
MDR Report Key | 7864297 |
MDR Text Key | 119818741 |
Report Number | 1526439-2018-50860 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 10705034083650 |
UDI-Public | (01)10705034083650 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K160904 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/11/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 179799645 |
Device Catalogue Number | 179799645 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/14/2018 |
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? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|