Brand Name | FLANGE FIXTURE AND ABUTMENT |
Type of Device | LXB |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
po box 82 |
mölnlycke, se 435-2 2 |
SW 435-22 |
|
Manufacturer Contact |
angel
wright
|
13059 east peakview avenue |
centennial, CO 80111
|
3037909010
|
|
MDR Report Key | 5332998 |
MDR Text Key | 34638597 |
Report Number | 6000034-2015-02660 |
Device Sequence Number | 1 |
Product Code |
LXB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K945154 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/07/2015 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | N/A |
Device Catalogue Number | 93100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/07/2015
|
Initial Date FDA Received | 12/29/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 65 YR |