MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-05 for AXOR II 1288 manufactured by Integrum Ab.
[101493158]
The prosthetic limb dropped off while walking. The patient fell which resulted in visit to the hospital, and the patient was in lot of pain. She had pulled/ torn some muscles and takes pain medication. The prosthetic device was replaced. Cpo informed integrum that the patient experience no problems with her current prosthetic device and is recovering well from her fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00001 |
| MDR Report Key | 7313024 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-05 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-01-19 |
| Date Facility Aware | 2018-02-06 |
| Report Date | 2018-02-06 |
| Date Reported to Mfgr | 2018-02-06 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2015-09-15 |
| Date Added to Maude | 2018-03-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NIKLAS HOFVERBERG |
| Manufacturer Street | KROKSLATTS FABRIKER 50 SUITE 1780 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer Phone | 6508674487 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43137 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXOR II |
| Generic Name | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2018-03-05 |
| Returned To Mfg | 2018-02-09 |
| Model Number | 1288 |
| Catalog Number | 1288 |
| Lot Number | U77485-1-4 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 27 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSL?TTS FABRIKER 50 43137 M?LNDAL M?LNDAL, M?LNDAL 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-03-05 |