Brand Name | UNKN PIP IMPL |
Type of Device | HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO |
Manufacturer (Section D) |
ASCENSION ORTHOPEDICS, INC. |
11101 metric blvd |
austin TX 78758 |
|
Manufacturer (Section G) |
ASCENSION ORTHOPEDICS, INC. |
11101 metric blvd |
|
austin TX 78758 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 16096244 |
MDR Text Key | 306634066 |
Report Number | 3002788818-2023-00001 |
Device Sequence Number | 1 |
Product Code |
OMX
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Literature |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/04/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/04/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |
|
|