Brand Name | BIOMET MICROFIXATION FACIAL PLATING SYSTEM |
Type of Device | 90 DEGREE CONTRA ANGLE SCREWDRIVER |
Manufacturer (Section D) |
BIOMET MICROFIXATION |
1520 tradeport drive |
jacksonville FL 32218 |
|
Manufacturer (Section G) |
BIOMET MICROFIXATION |
1520 tradeport drive |
|
jacksonville FL 32218 |
|
Manufacturer Contact |
michelle
cole
|
1520 tradeport drive |
jacksonville, FL 32218
|
9047414400
|
|
MDR Report Key | 6639800 |
MDR Text Key | 77558140 |
Report Number | 0001032347-2017-00499 |
Device Sequence Number | 1 |
Product Code |
JEY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK121589 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/14/2017 |
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 Model Number | N/A |
Device Catalogue Number | 24-1189 |
Device Lot Number | 172350 |
Other Device ID Number | (01)00841036123130(10)172350 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/07/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/22/2017
|
Initial Date FDA Received | 06/14/2017 |
Supplement Dates Manufacturer Received | 08/27/2017
|
Supplement Dates FDA Received | 09/22/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/18/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |