MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-24 for OPRA IMPLANT SYSTEM IBC0011 manufactured by Integrum Ab.
[124966551]
A fractured fixture removal was reported. The fixture was in use for 10 years before removal (expected life time of the device) and therefore this is not considered an early failure. The treating surgeon has reported pain when loading and possible infection with no conclusive data. The fixture fractured at the expected site where the weakest point in the mechanical design is found (transversal hole after central screw opening) in the presence of lack of bone support. Xray examination identified very advanced bone resorption and bone support loosening of more than half the length of the implant. In addition soft tissue problems were also observed. A partially osseointegrated implant cannot withstand a full-scale functional loading due to reduction of bone-implant interface strength. Previous mechanical testing and fem simulations have identified a significant decrease in the load bearing capacity for the opra implant system in the presence of bone resorption (lack of bone support). There is no need for further investigation, the failure cause is known as reduced load bearing capacity of the implant in the absence of proper bone support from osseointegration. The failure occurred after 10 years of implantation and therefore is not considered an early failure from a possible manufacturing deviation. Fractured fixture. The fixture was in use for 10 years before removal (expected life time of the device). No deviation in batch documentation.
Patient Sequence No: 1, Text Type: N, H10
[124966552]
Fractured fixture. No evidence of a manufacturing deviation, which could have lead to the failure, was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00015 |
| MDR Report Key | 8001834 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-08 |
| Date Facility Aware | 2018-10-08 |
| Report Date | 2018-10-08 |
| Date Reported to Mfgr | 2018-10-08 |
| Date Mfgr Received | 2018-10-08 |
| Device Manufacturer Date | 2007-09-28 |
| Date Added to Maude | 2018-10-24 |
| 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 |
| 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 |
| Product Code | PJY |
| Date Received | 2018-10-24 |
| Model Number | IBC0011 |
| Catalog Number | IBC0011 |
| Lot Number | 87540 |
| Device Expiration Date | 2012-09-28 |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-24 |