Brand Name | SUTURE ANCHOR, BIO-COMP PUSHLOCK, 2.9 X 12.5MM |
Type of Device | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 194 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 194 |
|
Manufacturer Contact |
vik
bajnath, sr. mdr analyst.
|
1370 creekside boulevard |
naples, FL 34108-1945
|
8009337001
|
|
MDR Report Key | 3699808 |
MDR Text Key | 4230100 |
Report Number | 1220246-2014-00043 |
Device Sequence Number | 1 |
Product Code |
MAI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101679 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative,Distributor |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
02/27/2014 |
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 |
Health Professional
|
Device Expiration Date | 06/01/2015 |
Device Catalogue Number | AR-2923BC |
Device Lot Number | 822141 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/27/2014
|
Initial Date FDA Received | 03/26/2014 |
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 35 YR |