Brand Name | DONJOY TITANIUM, A22 |
Type of Device | JOINT, KNEE, EXTERNAL BRACE |
Manufacturer (Section D) |
DJO LLC - VISTA |
1430 decision street |
vista, ca |
|
Manufacturer (Section G) |
DJO LLC - VMC |
3151 scott street |
|
vista, ca |
|
Manufacturer Contact |
christine
bonczyk
|
2900 lake vista drive |
lewisville, tx
|
|
MDR Report Key | 10247882 |
MDR Text Key | 198154667 |
Report Number | 3012446970-2020-00021 |
Device Sequence Number | 1 |
Product Code |
ITQ
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/08/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | CONV TITANIUM |
Was Device Available for Evaluation? |
No
|
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 |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|