MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-11 for OPRA IMPLANT SYSTEM 1804 manufactured by Integrum Ab.
[135859368]
Fixture loosening. No osseointegration. The patient had surgery s1 (b)(6) 2017 and then he had psychological problems which delayed surgery s2 until (b)(6) 2019. At surgery s2 it was discovered that the implant was partly not osseointegrated. Batch documentation reviewed (doc (b)(4)). It was released with concession doc. (b)(4) (rational doc. (b)(4)). The product performance will not be affected according to concession documentation. Manufacturing date: 2017-03-24.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2019-00019 |
| MDR Report Key | 8327705 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-11 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-23 |
| Date Facility Aware | 2019-02-04 |
| Report Date | 2019-01-31 |
| Date Reported to Mfgr | 2019-01-31 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-02-11 |
| 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 BIOHELIX 18X80-12 |
| Product Code | PJY |
| Date Received | 2019-02-11 |
| Model Number | 1804 |
| Catalog Number | 1804 |
| Lot Number | R5373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 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 | 2019-02-11 |