Brand Name | MULTIFIX P KNOTLESS FIXATION DEVICE |
Type of Device | FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD |
Manufacturer (Section D) |
ARTHROCARE CORPORATION |
austin TX |
|
Manufacturer (Section G) |
ARTHROCARE COSTA RICA |
|
|
la aurora, heredia |
CS
|
|
Manufacturer Contact |
wendy
laird
|
7000 w william cannon dr., bldg 1 |
austin, TX 78735
|
5123585933
|
|
MDR Report Key | 4669373 |
MDR Text Key | 19359821 |
Report Number | 3006524618-2015-00056 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
PMA/PMN Number | K120096 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
03/11/2015 |
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 | 07/01/2015 |
Device Catalogue Number | OM-1300 |
Device Lot Number | 1028091 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/11/2015
|
Initial Date FDA Received | 04/06/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/20/2012 |
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) |
Other;
|
Patient Age | 49 YR |
|
|