MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for OPRA FIXTURE manufactured by Integrum Ab.
[130171988]
Integrum has repeatedly tried to get further information regarding the case, but have not received any report form or any other information.
Patient Sequence No: 1, Text Type: N, H10
[130172029]
Mail received from prof. (b)(6): unfortunately we have to explant the transfemoral opra kit in patient (b)(6). S1 en s2 surgery was performed in 2012. Although had annually a period of confident infection he developed in last year an osteomyelitis. Extensive nettoyage could not achieve control of this infection with streptococcus intermedius. Patient demand to remove the opra. We need an abutment and fixture kit before (b)(6). Fixture 18,5 80 and abutment 72x with screw 82. Integrum has after receiving this information repeatedly tried to get further information regarding the case, but have not received any report form or any other information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00017 |
| MDR Report Key | 8156239 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-08 |
| Date Facility Aware | 2018-11-08 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-12-12 |
| 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, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| 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 | OPRA FIXTURE |
| Generic Name | OPRA FIXTURE |
| Product Code | PJY |
| Date Received | 2018-12-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSLATTS FABRIKER 50 MOLNDAL, VASTRA GOTALAND 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-12 |