Brand Name | EXPEDIUM VERSE |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE |
Manufacturer (Section D) |
DEPUY SYNTHES SPINE |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
MEDOS INTERNATIONAL SARL |
chemin blanc 38 |
|
le locle CH-24 00 |
SZ
CH-2400
|
|
Manufacturer Contact |
jason
busch
|
325 paramount drive |
raynham, MA 02767
|
5088808201
|
|
MDR Report Key | 6951522 |
MDR Text Key | 89380421 |
Report Number | 1526439-2017-10840 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 10705034466132 |
UDI-Public | (01)10705034466132 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142185 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/25/2017 |
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 |
Physician
|
Device Model Number | 199721000 |
Device Catalogue Number | 199721000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/25/2017 |
Initial Date FDA Received | 10/16/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Disability;
|
Patient Age | 14 YR |
Patient Weight | 40 |