Brand Name | GLENOID, PE WITH PEG, LARGE |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
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, adverrse events
|
1370 creekside boulevard |
naples, FL 34108-1945
|
8009337013
|
|
MDR Report Key | 6860661 |
MDR Text Key | 85906488 |
Report Number | 1220246-2017-00327 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00888867057333 |
UDI-Public | 00888867057333 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,study |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/22/2017 |
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 Catalogue Number | AR-9105-03 |
Device Lot Number | 1321008 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/07/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/12/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
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;
|
|
|