Brand Name | 3.5X42MM CORTICAL SCREW STE |
Type of Device | ROD, FIXATION |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 6910161 |
MDR Text Key | 89462499 |
Report Number | 0001825034-2017-07676 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | PN/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/02/2017 |
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 |
Health Professional
|
Device Expiration Date | 11/30/2023 |
Device Model Number | N/A |
Device Catalogue Number | 855037042 |
Device Lot Number | DPMB7W |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/28/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/17/2014 |
Initial Date FDA Received | 10/03/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/15/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |