MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for AXOR II manufactured by .
[114692559]
The patient lost his prosthesis 4 times in a weekend walking in streets. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00006 |
| MDR Report Key | 7694904 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-06-07 |
| Date Facility Aware | 2018-06-15 |
| Report Date | 2018-06-15 |
| Date Reported to Mfgr | 2018-06-15 |
| Date Mfgr Received | 2018-06-15 |
| Device Manufacturer Date | 2016-05-26 |
| Date Added to Maude | 2018-07-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR NIKLAS HOFVERBERG |
| Manufacturer Street | KROKSL |
| Manufacturer City | GOTHENBURG, V 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSL |
| Manufacturer City | MOLNDAL, 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXOR II |
| Generic Name | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2018-07-17 |
| Returned To Mfg | 2018-06-20 |
| Device Availability | R |
| Device Age | 24 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |