Brand Name | 55 MM LEFT STANDARD MANDIBLE |
Type of Device | MANDIBLE IMPLANT |
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 | 6135623 |
MDR Text Key | 61140788 |
Report Number | 0001032347-2016-00707 |
Device Sequence Number | 1 |
Product Code |
LZD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PP020016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
11/02/2016 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 24-6556 |
Device Lot Number | 463830B |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/02/2016 |
Initial Date FDA Received | 11/30/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|