Brand Name | GRAPPLER SUTURE ANCHOR SYSTEM |
Type of Device | GRAPPLER SUTURE ANCHOR, TITANIUM, Ø3.0 X 10MM, STERILE KIT, PRODUCT |
Manufacturer (Section D) |
PARAGON 28, INC |
14445 grasslands dr |
englewood CO 80112 |
|
Manufacturer Contact |
jenny
conger
|
14445 grasslands dr |
englewood, CO 80112
|
|
MDR Report Key | 15124428 |
MDR Text Key | 297231918 |
Report Number | 3008650117-2022-00098 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/28/2022 |
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 | P44-110-3010-SK |
Device Lot Number | 5007499 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/28/2022 |
Initial Date FDA Received | 07/28/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 30 YR |
Patient Sex | Male |
Patient Weight | 68 KG |
|
|