MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for AXOR II 1288 manufactured by Integrum Ab.
[117851949]
On (b)(6) 2018: emdr report submitted. The probable cause of the failure is addressed in the ongoing capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[117852050]
Faulty axor. Patient complaints that his axor ii "fell off the abutment". He states that axor loosens itself despite retightening multiple times per day. Proximal grip doesn't recoil when released. It's stiff and almost impossible to rotate. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00008 |
| MDR Report Key | 7799104 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-06-07 |
| Date Facility Aware | 2018-06-07 |
| Report Date | 2018-06-07 |
| Date Reported to Mfgr | 2018-06-07 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2017-04-10 |
| Date Added to Maude | 2018-08-20 |
| 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. NIKLAS HOFVERBERG |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| 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 | 2018-08-20 |
| Returned To Mfg | 2018-06-27 |
| Model Number | 1288 |
| Catalog Number | 1288 |
| Lot Number | U86792-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSLATTS FABRIKER 50 MOLNDAL, 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-20 |