Brand Name | TENOTAC SOFT TISSUE FIXATION SYSTEM |
Type of Device | TENOTAC STERILE KIT SYSTEM, Ø8MM X 2.2MM X 7.5MM |
Manufacturer (Section D) |
PARAGON 28, INC |
14445 grasslands dr |
englewood CO 80112 |
|
Manufacturer Contact |
jenny
conger
|
14445 grasslands dr |
englewood, CO 80112
|
7203721212
|
|
MDR Report Key | 16403363 |
MDR Text Key | 309863551 |
Report Number | 3008650117-2023-00040 |
Device Sequence Number | 1 |
Product Code |
HWC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
02/17/2023 |
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 |
Lay User/Patient
|
Device Model Number | P42-222-0075-SK |
Device Catalogue Number | P42-222-0075-SK |
Device Lot Number | 260A05922A01 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/27/2023 |
Initial Date FDA Received | 02/20/2023 |
Supplement Dates Manufacturer Received | 01/27/2023
|
Supplement Dates FDA Received | 03/08/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/28/2022 |
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) |
Required Intervention;
Other;
|
Patient Age | 55 YR |
Patient Sex | Male |
|
|