MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for AXOR II 1288 manufactured by Integrum Ab.
[100675153]
Problems to attach and detach the prosthesis to the abutment. There is sound and grinding and binding when turning the axor top. Inability to fully tighten - the prosthesis falls off. No harm to the patient. The product has been returned to integrum for service repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2017-00001 |
| MDR Report Key | 7282062 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-01-18 |
| Report Date | 2017-12-12 |
| Date Reported to Mfgr | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2016-11-28 |
| Date Added to Maude | 2018-02-20 |
| 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 SUITE 1780 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND CA 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 |
| 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 | 2018-02-20 |
| Returned To Mfg | 2018-01-19 |
| Model Number | 1288 |
| Catalog Number | 1288 |
| Lot Number | U82023-2-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSLATTS FABRIKER 50 43137 M?LNDAL MOLNDAL, VASTRA GOTALAND 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |