Brand Name | X-LARGE OPEN POLY SCREW 5 35MM |
Type of Device | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, |
Manufacturer (Section D) |
ZIMMER BIOMET SPINE INC. |
10225 westmoor dr. |
westminster CO 80021 |
|
Manufacturer (Section G) |
ZIMMER BIOMET SPINE INC. |
10225 westmoor dr. |
na |
westminster CO 80021 |
|
Manufacturer Contact |
geoffrey
gannon
|
10225 westmoor dr. |
na |
westminster, CO 80021
|
3034437500
|
|
MDR Report Key | 6668784 |
MDR Text Key | 78454465 |
Report Number | 3012447612-2017-00244 |
Device Sequence Number | 1 |
Product Code |
MNI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK052566 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/29/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 2120-5535 |
Device Lot Number | 48KG |
Other Device ID Number | (01)00889024332645 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/01/2017
|
Initial Date FDA Received | 06/26/2017 |
Supplement Dates Manufacturer Received | 11/28/2017
|
Supplement Dates FDA Received | 11/29/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/12/2007 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|