Brand Name | MMSI ROD PREBENT, 5.5 X45MM, T |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE |
Manufacturer (Section D) |
DEPUY SPINE INC |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
MEDOS INT SPINE |
chemin blanc 38 |
|
le locle |
CH
|
|
Manufacturer Contact |
jason
busch
|
325 paramount drive |
raynham, MA 02767
|
5088808100
|
|
MDR Report Key | 7263520 |
MDR Text Key | 99807058 |
Report Number | 1526439-2018-50125 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 10705034066592 |
UDI-Public | 10705034066592 |
Combination Product (y/n) | N |
PMA/PMN Number | K955348 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/12/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 179712045 |
Device Catalogue Number | 179772045 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/31/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 46 YR |
|
|