Brand Name | REVERSE RESECTION JIG - DELTOPECTORAL APPROACH |
Type of Device | SMR REVERSE RESECTION JIG |
Manufacturer (Section D) |
LIMACORPORATE S.P.A. |
via nazionale,52 |
villanova di san daniele, 33038 |
IT 33038 |
|
Manufacturer (Section G) |
LIMACORPORATE S.P.A. |
via nazionale,52 |
|
villanova di san daniele, 33038 |
IT
33038
|
|
Manufacturer Contact |
|
MDR Report Key | 7081980 |
MDR Text Key | 94811162 |
Report Number | 3008021110-2017-00110 |
Device Sequence Number | 1 |
Product Code |
KWT
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K100858 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
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 Model Number | 9013.52.304 |
Device Lot Number | 15AQ01C |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/05/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|