MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-06 for OPRA IMPLANT SYSTEM IBC0012 manufactured by Integrum Ab.
[178319562]
Integrum was informed 9th of january about fixture loosening (fixture will be removed). Patient has had a history of infections and pain. Infection will be treated by debridement, local and systemic antibiotics. Fixture has been removed in surgery and will not be replaced. No further information will be obtained. Since fixture will not be returned to integrum.
Patient Sequence No: 1, Text Type: N, H10
[178319563]
9th of january 2020 integrum received information that patient will remove fixture due to fixture loosening. Patient has had a history of infections and pain. Infection will be treated by debridement, local and systemic antibiotics. Batch documentation reviewed. No deviations found in product. Patient had the implant for 14 years and therefore this is not considered an early failure. 4t og (b)(6) 2020 fixture removal surgery performed. Fixture will not be replaced. No further information will be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2020-00028 |
| MDR Report Key | 9678162 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-04 |
| Device Manufacturer Date | 2010-12-08 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS SALLY SKOG |
| 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 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPRA IMPLANT SYSTEM |
| Generic Name | OPRA IMPLANT FIXTURE 18MM |
| Product Code | PJY |
| Date Received | 2020-02-06 |
| Model Number | IBC0012 |
| Catalog Number | IBC0012 |
| Lot Number | 20020829 |
| Device Expiration Date | 2007-10-01 |
| Device Availability | N |
| Device Age | 18 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-06 |