Brand Name | SUTURE ANCHOR, BIO-CORKSCREW FT |
Type of Device | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
ARTHREX INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
vik
bajnath, adverse events
|
1370 creekside boulevard |
naples, FL 34108-1945
|
8009337013
|
|
MDR Report Key | 7600207 |
MDR Text Key | 111013934 |
Report Number | 1220246-2018-00238 |
Device Sequence Number | 1 |
Product Code |
MAI
|
UDI-Device Identifier | 00888867023352 |
UDI-Public | 00888867023352 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K082810 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
06/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/14/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/01/2019 |
Device Catalogue Number | AR-1927BCF |
Device Lot Number | 10186194 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 05/23/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/01/2018 |
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;
|