MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for MODULAR POLYCENTRIC EBS KNEE JOINT 3R60 manufactured by Ottobock Se & Co Kgaa.
| Report Number | 9616494-2020-00003 |
| MDR Report Key | 9834205 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DOMINIK SCHMIDT |
| Manufacturer Street | MAX-NAEDER-STR. 15 |
| Manufacturer City | DUDERSTADT, 37115 |
| Manufacturer Country | GM |
| Manufacturer Postal | 37115 |
| Manufacturer G1 | OTTOBOCK SE & CO KGAA |
| Manufacturer Street | MAX-NAEDER-STR. 15 |
| Manufacturer City | DUDERSTADT, 37115 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 37115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODULAR POLYCENTRIC EBS KNEE JOINT |
| Generic Name | MODULAR POLYCENTRIC EBS KNEE JOINT |
| Product Code | ISY |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-18 |
| Model Number | 3R60 |
| Catalog Number | 3R60 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTOBOCK SE & CO KGAA |
| Manufacturer Address | MAX-NAEDER-STR. 15 DUDERSTADT, 37115 GM 37115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |