Brand Name | SINGLE INNER POLYAXIAL SCREW 5.5 X 6.00 X 45MM |
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 | 5904721 |
MDR Text Key | 53037001 |
Report Number | 1526439-2016-10613 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
08/01/2016 |
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 Catalogue Number | 179712645 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
08/01/2016 |
Initial Date FDA Received | 08/25/2016 |
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? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Other;
Required Intervention;
|