Brand Name | OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
STRYKER ENDOSCOPY-SAN JOSE |
5900 optical court |
san jose CA 95138 |
|
Manufacturer (Section G) |
STRYKER ENDOSCOPY-SAN JOSE |
5900 optical court |
|
san jose CA 95138 |
|
Manufacturer Contact |
andrea
zenere
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 8495598 |
MDR Text Key | 141339141 |
Report Number | 0002936485-2019-00136 |
Device Sequence Number | 1 |
Product Code |
MBI
|
UDI-Device Identifier | 37613327464833 |
UDI-Public | 37613327464833 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181083 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/09/2019 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 3910-500-472 |
Device Lot Number | 18353AG2 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/18/2019
|
Initial Date FDA Received | 04/09/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/19/2018 |
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;
|
Patient Age | 51 YR |