Brand Name | CONVENTUS PHS SYSTEM |
Type of Device | PLATE, FIXATION, BONE |
Manufacturer (Section D) |
CONVENTUS ORTHOPAEDICS, INC. |
10200 73rd avenue north |
suite 122 |
maple grove MN 55369 |
|
Manufacturer (Section G) |
CONVENTUS ORTHOPAEDICS, INC. |
10200 73rd avenue north |
suite 122 |
maple grove MN 55369 |
|
Manufacturer Contact |
kenneth
block
|
800 e. campbell road |
suite 202 |
richardson, TX 75081
|
9724809554
|
|
MDR Report Key | 11032805 |
MDR Text Key | 226640313 |
Report Number | 3008480376-2020-00021 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141737 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/17/2020 |
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
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/21/2020 |
Initial Date FDA Received | 12/17/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 79 YR |
Patient Weight | 91 |
|
|