MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-06 for OPRA IMPLANT SYSTEM IBC0010 A manufactured by Integrum Ab.
[138071260]
Fixture loosening. Fixture removal (b)(6) 2019. Fixture were inserted (b)(6) 2007. According to surgeon the fixture was removed due to bone support loosening and infection. The distal bone was clearly infected with multiple lytic areas. The fixture failure has appeared almost 12 years after installation and therefore this is not considered as a early failure and could not be related to a manufacturing issue. Integrum will not receive any further information about the reason for the infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2019-00020 |
| MDR Report Key | 8396623 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-29 |
| Date Facility Aware | 2019-01-31 |
| Report Date | 2019-01-31 |
| Date Reported to Mfgr | 2019-01-31 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPRA IMPLANT SYSTEM |
| Generic Name | FIXTURE 17 MM |
| Product Code | PJY |
| Date Received | 2019-03-06 |
| Model Number | IBC0010 A |
| Lot Number | 20020829 |
| Device Expiration Date | 2002-10-01 |
| Device Availability | N |
| Device Age | 12 YR |
| 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 | 2019-03-06 |