Brand Name | COUNTER ROTATION HEX WRENCH |
Type of Device | WRENCH (RATCHETING HANDLES) |
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 | 7451484 |
MDR Text Key | 106266935 |
Report Number | 3012447612-2018-00355 |
Device Sequence Number | 1 |
Product Code |
HXC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PEXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/17/2018 |
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 | 29008 |
Device Lot Number | PN25A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/28/2018 |
Initial Date FDA Received | 04/23/2018 |
Supplement Dates Manufacturer Received | 09/28/2018
|
Supplement Dates FDA Received | 10/17/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/11/2007 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |