Brand Name | MODULAR POLYCENTRIC EBS KNEE JOINT |
Type of Device | MODULAR POLYCENTRIC EBS KNEE JOINT |
Manufacturer (Section D) |
OTTOBOCK SE & CO KGAA |
max-naeder-str. 15 |
duderstadt, 37115 |
GM 37115 |
|
Manufacturer (Section G) |
OTTOBOCK SE & CO KGAA |
max-naeder-str. 15 |
|
duderstadt, 37115 |
GM
37115
|
|
Manufacturer Contact |
dominik
schmidt
|
max-naeder-str. 15 |
duderstadt, 37115
|
GM
37115
|
|
MDR Report Key | 9914928 |
MDR Text Key | 192149312 |
Report Number | 9616494-2020-00008 |
Device Sequence Number | 1 |
Product Code |
ISY
|
Combination Product (y/n) | N |
Reporter Country Code | RS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/02/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 3R60 |
Device Catalogue Number | 3R60 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/30/2020 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/31/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 | 46 YR |
Patient Weight | 80 |